Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)

• Sponsor: Smith & Nephew, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01084772
• Collaborator: (none)
• Enrollment: 134
• Locations: 7
• Arms: 2
• Actual Duration (Months): 38.3
• Patients Per Site: 19.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary objective of this study is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. This study does not involve treatment or investigational products, as all components are FDA cleared and are commercially available.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis of Knee	Other: VISIONAIRE Total Knee Arthroplasty; Other: Standard Total Knee Arthroplasty	N/A

Detailed Description

This is a prospective study comparing VISIONAIRE™ to standard TKA instrumentation. The objective of this study is to evaluate the safety and efficacy of TKA using VISIONAIRE™ when compared with standard instrumentation, including device survival, improvement in function and implant alignment after TKA. This study will also document any device-related, surgical complications and/or adverse radiographic observations.

In contrast with the control group clinical outcomes following TKA completed with VISIONAIRE™ have yet to be assessed. The current investigation will determine if there is any difference in TKA outcomes when VISIONAIRE™ patient matched technology is utilized versus standard instrumentation. All patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. If the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. Patients requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith & Nephew) total knee implant systems. Standard instrumentation will be used to assist the surgeon in placing the implant in the control group. In the VISIONAIRE™ group, standard instrumentation will not be used in the surgery. Patients randomized to the VISIONAIRE™ arm will have an MRI preoperatively that will be used to create the customized cutting blocks. All patients will have an x-ray at each postoperative interval.

Study Design

• Study Type: Interventional
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Multicenter, Randomized, Clinical Outcome of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty
• Actual Study Start Date: Jun 21, 2012
• Actual Primary Completion Date: Apr 15, 2014
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: VISIONAIRE Instrumentation TKA with VISIONAIRE instrumentation	Other: VISIONAIRE Total Knee Arthroplasty; TKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment.
Other: Standard Instrumentation TKA with standard instrumentation	Other: Standard Total Knee Arthroplasty; TKA will be performed with standard instrumentation, depending on randomization assignment.

Outcome Measures

Primary Outcome Measures

1. Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score [2 years postoperatively]

   The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.

2. Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire [2 years postoperatively]

   The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit.

Secondary Outcome Measures

1. Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray [3 months postoperative]

   Long radiographic anterior-posterior (AP) (full-leg standing x-rays) of the entire limb are superior for measuring alignment of the knee as the limb mechanical axes may be more precisely computed. For full-leg x-rays, 2 lines were drawn on the radiograph. First, a line was drawn from the center of the femoral head to the center of the femoral intercondylar notch and the line was extended through to the ankle. Second, a line was drawn from the center of the tibial spine to the center of the ankle talus. The angle between the first and second line was measured to determine mechanical alignment and assessed as either neutral (0 degrees) or a number of degrees of varus or valgus.

2. Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively [Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively]

   Evaluation of KOOS questionnaire total scores including categories for symptoms, pain, function of daily living, function of sports and recreational activities, and quality of life. KOOS total scores ranged from 0 to 100, with 0 indicating worst (no function) and 100 indicating no symptoms at all.

3. Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively [1 year postoperatively]

   X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm). Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.

4. Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively [1 year postoperatively]

   X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.

5. Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively [2 years postoperatively]

   X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm), lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.

6. Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively [2 years postoperatively]

   X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.

7. Evaluation of Health Economic Criteria - Surgical Time Details [During and immediately following surgery]

   Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.

8. Evaluation of Health Economic Criteria - Blood Loss [During and immediately following surgery]

   Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.

9. Evaluation of Health Economic Criteria - Incision Length [During and immediately following surgery]

   Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.

10. Evaluation of Health Economic Criteria - Instrument Tray Use [During and immediately following surgery]

    Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.

11. Evaluation of Health Economic Surgical Criteria [During and immediately following surgery]

    Analysis of health data captured during and immediately following surgery: surgical approach, cut order, final status of posterior cruciate ligament (PCL), and need for perioperative prophylaxis antibiotics.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients must meet all of the inclusion criteria.

1. Patient diagnosed with degenerative arthritis of the knee requiring a unilateral primary TKA.

2. Patient is of legal age to consent and is skeletally mature.

3. Patient is willing to sign and date an ethics-approved consent form.

4. Patient is willing to be available for two-year follow-up postoperatively

Exclusion Criteria:

Patients must not meet any of the exclusion criteria.

1. Patient is known to have poor bone stock making a TKA unjustifiable.

2. Patient is immuno-suppressed.

3. Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.

4. Patient is pregnant or may become pregnant during the course of the study.

5. Patient has a history of prior ipsilateral major knee surgery (e.g. arthroplasty, high tibial osteotomy, or tibial plateau fracture). Minor prior procedures such as ACL repair, meniscectomy, or arthroscopy are not excluded.

6. Patient has active, localized or systemic infection.

7. Patient is severely overweight (BMI >40).

8. Patient is a prisoner.

9. Subject has a significant MRI (magnetic resonance imaging) exclusion or contraindication.

10. Patient has had a total joint arthroplasty of the contralateral limb in the last 12 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthopaedic Surgery Specialist, Ltd.	Park Ridge	Illinois	United States	60068
2	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62794-9679
3	Town & Country Orthopedics	Saint Louis	Missouri	United States	63131
4	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-1080
5	Wake Forest University School of Medicine	Winston-Salem	North Carolina	United States	27157-1070
6	Slocum Research & Education Foundation	Eugene	Oregon	United States	97401
7	Malabar Orthopaedic Clinic	Windsor	Victoria	Australia	3181

Sponsors and Collaborators

• Smith & Nephew, Inc.

Investigators

• Study Director: Beate Hanson, MD, PhD, Smith & Nephew, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Smith & Nephew, Inc.
• ClinicalTrials.gov Identifier: NCT01084772
• Other Study ID Numbers: VISSTD01
• First Posted: Mar 10, 2010
• Last Update Posted: Apr 3, 2020
• Last Verified: Mar 1, 2020

• Additional relevant MeSH terms: Osteoarthritis

Study Results

Participant Flow

Recruitment Details	The study was planned to enroll 196 subjects; 134 subjects were recruited to the study prior to its termination due to insufficient total enrollment. Subjects were enrolled from 21 June 2012 to 15 April 2014. Early termination was approved May 2014 and sites were officially notified of study termination in September 2015.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Period Title: Baseline
STARTED	68	66
COMPLETED	61	60
NOT COMPLETED	7	6
Period Title: Baseline
STARTED	61	60
COMPLETED	58	58
NOT COMPLETED	3	2
Period Title: Baseline
STARTED	58	58
COMPLETED	55	50
NOT COMPLETED	3	8
Period Title: Baseline
STARTED	55	50
COMPLETED	46	46
NOT COMPLETED	9	4

Baseline Characteristics

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation	Total
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.	Total of all reporting groups
Overall Participants	68	65	133
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.7 (8.71)	67.5 (7.70)	68.9 (8.2)
Sex: Female, Male (Count of Participants)
Female	40 58.8%	37 56.9%	77 57.9%
Male	28 41.2%	28 43.1%	56 42.1%
Race/Ethnicity, Customized (Count of Participants)
White, Not Hispanic	52 76.5%	46 70.8%	98 73.7%
Black, Not Hispanic	2 2.9%	3 4.6%	5 3.8%
Hispanic	1 1.5%	0 0%	1 0.8%
Other	0 0%	1 1.5%	1 0.8%
Aus-Asian	1 1.5%	1 1.5%	2 1.5%
Aus-Caucasian	12 17.6%	14 21.5%	26 19.5%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	168.0 (9.84)	168.0 (10.12)	168.0 (9.94)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	88.3 (17.80)	83.7 (17.77)	86.1 (17.86)

Outcome Measures

1. Primary Outcome

Title	Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Total Score
Description	The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS Total Score (0-100 points) included a combined evaluation of joint motion (0-25 points), instability (0-25 points), alignment (0-25 points), and symptoms (0-25 points). A higher score indicated a better outcome for subjects.
Time Frame	2 years postoperatively

Outcome Measure Data

Analysis Population Description

The Knee Society Clinical Score was not completed for all enrolled subjects. Data was only available for 83 subjects.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	42	41
Mean (Standard Deviation) [score on a scale]	91.4 (13.7)	94.3 (8.9)

2. Primary Outcome

Title	Knee Society Clinical (KSS) Score at 2 Years Following Surgery - Clinical Evaluation Questionnaire
Description	The KSS was used to rate both the prosthesis function and the patient's functional abilities after TKA. The KSS clinical evaluation included a questionnaire completed by the investigators to assess for pain, stability, flexion contracture, extension lag, and alignment and evaluated based on number of subjects experiencing any of these issues at the 2-year postoperative visit.
Time Frame	2 years postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	46	46
Pain - none	26 38.2%	27 41.5%
Pain - mild or occasional	12 17.6%	14 21.5%
Pain - stairs only	1 1.5%	1 1.5%
Pain - walking & stairs	1 1.5%	1 1.5%
Pain - moderate occasional	2 2.9%	1 1.5%
Pain - moderate continuous	3 4.4%	1 1.5%
Pain - severe	1 1.5%	0 0%
Pain - missing response	0 0%	1 1.5%
AP Stability - <5 mm	43 63.2%	43 66.2%
AP Stability - 5-10 mm	1 1.5%	1 1.5%
AP Stability - >10 mm	0 0%	1 1.5%
AP Stability - missing response	2 2.9%	1 1.5%
Medio-lateral Stability - <6 degrees	44 64.7%	44 67.7%
Medio-lateral Stability - 6-9 degrees	0 0%	0 0%
Medio-lateral Stability - 10-14 degrees	0 0%	0 0%
Medio-lateral Stability - >14 degrees	0 0%	1 1.5%
Medio-lateral Stability - missing response	2 2.9%	1 1.5%
Flexion Contracture - 0-4 degrees	42 61.8%	42 64.6%
Flexion Contracture - 5-10 degrees	2 2.9%	2 3.1%
Flexion Contracture - 11-15 degrees	0 0%	0 0%
Flexion Contracture - 16-20 degrees	0 0%	0 0%
Flexion Contracture - > 20 degrees	0 0%	0 0%
Flexion Contracture - missing response	2 2.9%	2 3.1%
Extension Lag - 0 degrees	43 63.2%	44 67.7%
Extension Lag - < 10 degrees	1 1.5%	0 0%
Extension Lag - 11-20 degrees	0 0%	0 0%
Extension Lag - > 20 degrees	0 0%	1 1.5%
Extension Lag - missing response	2 2.9%	1 1.5%
Alignment - 5 or 10 degrees valgus (normal)	40 58.8%	41 63.1%
Alignment - 4 or 11 degrees valgus	1 1.5%	1 1.5%
Alignment - 3 or 12 degrees valgus	1 1.5%	1 1.5%
Alignment - 2 or 13 degrees valgus	0 0%	0 0%
Alignment - 1 or 14 degrees valgus	0 0%	1 1.5%
Alignment - 0 or 15 degrees valgus	1 1.5%	0 0%
Alignment - varus or > 15 degrees valgus	0 0%	0 0%
Alignment - missing response	3 4.4%	2 3.1%

3. Secondary Outcome

Title	Evaluation of Mechanical Alignment Assessed as Either Neutral or Varus/Valgus 3 Months Postoperatively Using a Full Leg X-ray
Description	Long radiographic anterior-posterior (AP) (full-leg standing x-rays) of the entire limb are superior for measuring alignment of the knee as the limb mechanical axes may be more precisely computed. For full-leg x-rays, 2 lines were drawn on the radiograph. First, a line was drawn from the center of the femoral head to the center of the femoral intercondylar notch and the line was extended through to the ankle. Second, a line was drawn from the center of the tibial spine to the center of the ankle talus. The angle between the first and second line was measured to determine mechanical alignment and assessed as either neutral (0 degrees) or a number of degrees of varus or valgus.
Time Frame	3 months postoperative

Outcome Measure Data

Analysis Population Description

Evaluation of Mechanical Alignment 3 Months Postoperatively was not completed for all enrolled subjects. Only data for 88 participants was available.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	44	44
Alignment - Neutral	19 27.9%	10 15.4%
Varus	11 16.2%	28 43.1%
Valgus	14 20.6%	6 9.2%
Missing	0 0%	0 0%

4. Secondary Outcome

Title	Knee Injury and Osteoarthritis Outcome Score (KOOS) Preoperatively and Postoperatively
Description	Evaluation of KOOS questionnaire total scores including categories for symptoms, pain, function of daily living, function of sports and recreational activities, and quality of life. KOOS total scores ranged from 0 to 100, with 0 indicating worst (no function) and 100 indicating no symptoms at all.
Time Frame	Baseline (preoperative), 3 months, 1 year, and 2 years postoperatively

Outcome Measure Data

Analysis Population Description

Not all enrolled subjects completed the KOOS questionnaire at each time point.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	62	60
Pain - preoperative	40.9 (17.0)	43.9 (16.6)
Pain - 3 months postoperative	73.7 (15.5)	76.3 (16.1)
Pain - 1 year postoperative	85.4 (16.7)	88.5 (16.7)
Pain - 2 years postoperative	89.4 (13.2)	92.3 (10.2)
Symptoms - preoperative	46.6 (21.2)	49.9 (17.7)
Symptoms - 3 months postoperative	66.4 (17.5)	73.1 (13.6)
Symptoms - 1 year postoperative	81.6 (17.2)	82.5 (16.4)
Symptoms - 2 years postoperative	85.7 (10.9)	88.2 (9.4)
Activities of Daily Living (ADLs) - preoperative	46.5 (18.9)	51.4 (18.8)
ADLs - 3 months postoperative	78.8 (14.6)	84.1 (13.8)
ADLs - 1 year postoperative	86.8 (14.9)	89.5 (12.4)
ADLs - 2 years postoperative	89.3 (14.6)	92.3 (10.4)
Sports/Rec - preoperative	19.0 (19.0)	23.1 (22.8)
Sports/Rec - 3 months postoperative	42.4 (29.6)	48.2 (31.3)
Sports/Rec - 1 year postoperative	62.0 (32.0)	62.5 (32.6)
Sports/Rec - 2 years postoperative	74.9 (26.6)	74.4 (25.6)
Quality of Life (QoL) - preoperative	21.0 (17.2)	22.5 (17.2)
QoL - 3 months postoperative	58.6 (21.7)	64.1 (19.9)
QoL - 1 year postoperative	68.1 (26.2)	72.9 (23.7)
QoL - 2 years postoperative	75.1 (23.2)	78.0 (18.3)

5. Secondary Outcome

Title	Serial Radiographic Evaluations to Assess Evidence of Loosening (Radiolucencies) by Measuring Lucent Zones at 1 Year Postoperatively
Description	X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm). Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.
Time Frame	1 year postoperatively

Outcome Measure Data

Analysis Population Description

Not all subjects completed the serial radiographic evaluations at the specified time points.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	54	50
Lucency - femoral zone 1 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 1 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 1 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 1 (> 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 2 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 2 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 2 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 2 (> 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 3 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 3 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 3 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 3 (> 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 4 (≤ 2 mm)	1 1.5%	0 0%
Lucency - femoral zone 4 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 4 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 4 (> 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 5 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 5 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 5 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 5 (> 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 6 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 6 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 6 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 6 (> 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 7 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 7 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 7 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 7 (> 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 1 (≤ 2 mm)	0 0%	0 0%
Lucency - patellar zone 1 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 1 (> 2 mm)	0 0%	0 0%
Lucency - patellar zone 1 (> 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 2 (≤ 2 mm)	0 0%	0 0%
Lucency - patellar zone 2 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 2 (> 2 mm)	0 0%	0 0%
Lucency - patellar zone 2 (> 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 3 (≤ 2 mm)	0 0%	0 0%
Lucency - patellar zone 3 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 3 (> 2 mm)	0 0%	0 0%
Lucency - patellar zone 3 (> 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 4 (≤ 2 mm)	0 0%	0 0%
Lucency - patellar zone 4 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 4 (> 2 mm)	0 0%	0 0%
Lucency - patellar zone 4 (> 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 5 (≤ 2 mm)	0 0%	0 0%
Lucency - patellar zone 5 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 5 (> 2 mm)	0 0%	0 0%
Lucency - patellar zone 5 (> 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 6 (≤ 2 mm)	0 0%	0 0%
Lucency - patellar zone 6 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 6 (> 2 mm)	0 0%	0 0%
Lucency - patellar zone 6 (> 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 7 (≤ 2 mm)	0 0%	0 0%
Lucency - patellar zone 7 (≤ 2 mm and progressive)	0 0%	0 0%
Lucency - patellar zone 7 (> 2 mm)	0 0%	0 0%
Lucency - patellar zone 7 (> 2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 1 (≤ 2 mm)	3 4.4%	0 0%
Lucency - tibial AP zone 1 (≤ 2 mm and progressive	0 0%	1 1.5%
Lucency - tibial AP zone 1 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 1 (> 2 mm and progressive	0 0%	0 0%
Lucency - tibial AP zone 2 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 2 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 2 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 2 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 3 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 3 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 3 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 3 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 4 (≤ 2 mm)	2 2.9%	1 1.5%
Lucency - tibial AP zone 4 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 4 (> 2 mm)	0 0%	1 1.5%
Lucency - tibial AP zone 4 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 5 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 5 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 5 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 5 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 6 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 6 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 6 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 6 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 7 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 7 (≤2 mm and progressive)	1 1.5%	0 0%
Lucency - tibial AP zone 7 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 7 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 8 (≤ 2 mm)	1 1.5%	0 0%
Lucency - tibial AP zone 8 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 8 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 8 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 9 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 9 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 9 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 9 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone A (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone A (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone A (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone A (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone B (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone B (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone B (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone B (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 1 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 1 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 1 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 1 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 2 (≤ 2 mm)	1 1.5%	0 0%
Lucency - tibial ML zone 2 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 2 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 2 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 3 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 3 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 3 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 3 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 4 (≤ 2 mm)	1 1.5%	0 0%
Lucency - tibial ML zone 4 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 4 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 4 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 5 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 5 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 5 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 5 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone A (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone A (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone A (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone A (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone B (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone B (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone B (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone B (>2 mm and progressive)	0 0%	0 0%

6. Secondary Outcome

Title	Radiographic Outcomes to Assess Evidence of Loosening at 1 Year Postoperatively
Description	X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.
Time Frame	1 year postoperatively

Outcome Measure Data

Analysis Population Description

Not all subjects completed the serial radiographic evaluations at the specified time points.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	54	50
Patella tracking - normal	53 77.9%	49 75.4%
Patella tracking - lateralized	1 1.5%	0 0%
Patella tracking - subluxation	0 0%	1 1.5%
Patella tracking - dislocation	0 0%	0 0%
Fixation - Ingrowth	35 51.5%	32 49.2%
Fixation - x-ray unclear	0 0%	1 1.5%
Fixation - indifferent, bone unchanged	34 50%	29 44.6%
Fixation - increased osseointegration	1 1.5%	2 3.1%
Fixation - bone loss	0 0%	0 0%
Fixation - implant at risk	0 0%	0 0%
Fixation - implant loosening	0 0%	0 0%
Fixation - revision indication	0 0%	0 0%
Observations - periosteal hypertrophy	0 0%	0 0%
Observations - osteolysis	0 0%	0 0%
Observations - subsidence	0 0%	0 0%
Observations - other	0 0%	0 0%
Evidence of deformity - no	54 79.4%	50 76.9%
Evidence of deformity - yes	0 0%	0 0%

7. Secondary Outcome

Title	Serial Radiographic Evaluations to Assess Evidence of Loosening at 2 Years Postoperatively
Description	X-ray evaluations performed to assess for evidence of implant loosening by radiolucencies (> 2 mm), lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed. The span of the bone-prosthesis interface, for each component, was broken down into zone systems. The scoring system for each of the 3 components was determined by measuring the radiolucent lines (mm) for each of these zones.
Time Frame	2 years postoperatively

Outcome Measure Data

Analysis Population Description

Not all subjects completed the serial radiographic evaluations at the specified time points.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	45	43
Lucency - femoral zone 1 (≤ 2 mm)	1 1.5%	0 0%
Lucency - femoral zone 1 (≤ 2 mm and progressive)	1 1.5%	0 0%
Lucency - femoral zone 1 (> 2 mm)	1 1.5%	0 0%
Lucency - femoral zone 1 (> 2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 2 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 2 (≤2 mm and progressive)	1 1.5%	0 0%
Lucency - femoral zone 2 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 2 (>2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 3 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 3 (≤2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 3 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 3 (>2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 4 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 4 (≤2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 4 (> 2 mm)	0 0%	0 0%
Lucency - femor0al zone 4 (>2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 5 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 5 (≤2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 5 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 5 (>2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 6 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 6 (≤2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 6 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 6 (>2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 7 (≤ 2 mm)	0 0%	0 0%
Lucency - femoral zone 7 (≤2 mm and progressive)	0 0%	0 0%
Lucency - femoral zone 7 (> 2 mm)	0 0%	0 0%
Lucency - femoral zone 7 (>2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 1 (≤ 2 mm)	0 0%	0 0%
Lucency - patella zone 1 (≤2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 1 (> 2 mm)	0 0%	0 0%
Lucency - patella zone 1 (>2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 2 (≤ 2 mm)	0 0%	0 0%
Lucency - patella zone 2 (≤2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 2 (> 2 mm)	0 0%	0 0%
Lucency - patella zone 2 (>2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 3 (≤ 2 mm)	0 0%	0 0%
Lucency - patella zone 3 (≤2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 3 (> 2 mm)	0 0%	0 0%
Lucency - patella zone 3 (>2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 4 (≤ 2 mm)	0 0%	0 0%
Lucency - patella zone 4 (≤2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 4 (> 2 mm)	0 0%	0 0%
Lucency - patella zone 4 (>2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 5 (≤ 2 mm)	0 0%	0 0%
Lucency - patella zone 5 (≤2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 5 (> 2 mm)	0 0%	0 0%
Lucency - patella zone 5 (>2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 6 (≤ 2 mm)	0 0%	0 0%
Lucency - patella zone 6 (≤2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 6 (> 2 mm)	0 0%	0 0%
Lucency - patella zone 6 (>2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 7 (≤ 2 mm)	0 0%	0 0%
Lucency - patella zone 7 (≤2 mm and progressive)	0 0%	0 0%
Lucency - patella zone 7 (> 2 mm)	0 0%	0 0%
Lucency - patella zone 7 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 1 (≤ 2 mm)	2 2.9%	0 0%
Lucency - tibial AP zone 1 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 1 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 1 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 2 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 2 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 2 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 2 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 3 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 3 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 3 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 3 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 4 (≤ 2 mm)	0 0%	1 1.5%
Lucency - tibial AP zone 4 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 4 (> 2 mm)	0 0%	1 1.5%
Lucency - tibial AP zone 4 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 5 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 5 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 5 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 5 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 6 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 6 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 6 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 6 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 7 (≤ 2 mm)	0 0%	1 1.5%
Lucency - tibial AP zone 7 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 7 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 7 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 8 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 8 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 8 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 8 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 9 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 9 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone 9 (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone 9 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone A (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone A (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone A (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone A (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone B (≤ 2 mm)	0 0%	0 0%
Lucency - tibial AP zone B (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial AP zone B (> 2 mm)	0 0%	0 0%
Lucency - tibial AP zone B (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 1 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 1 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 1 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 1 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 2 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 2 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 2 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 2 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 3 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 3 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 3 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 3 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 4 (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 4 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 4 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 4 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 5 (≤ 2 mm)	0 0%	1 1.5%
Lucency - tibial ML zone 5 (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone 5 (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone 5 (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone A (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone A (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone A (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone A (>2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone B (≤ 2 mm)	0 0%	0 0%
Lucency - tibial ML zone B (≤2 mm and progressive)	0 0%	0 0%
Lucency - tibial ML zone B (> 2 mm)	0 0%	0 0%
Lucency - tibial ML zone B (>2 mm and progressive)	0 0%	0 0%

8. Secondary Outcome

Title	Radiographic Outcomes to Assess Evidence of Loosening at 2 Years Postoperatively
Description	X-ray evaluations performed to assess for evidence of implant loosening by lack of evidence of surface wear or particulate debris generation, indications of early osteolysis, implant migration, and/or other clinical or radiographic abnormalities. Anterior-posterior (AP) and lateral serial x-ray evaluations were performed.
Time Frame	2 years postoperatively

Outcome Measure Data

Analysis Population Description

Not all subjects completed the serial radiographic evaluations at the specified time points.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	45	43
Patella tracking - normal	42 61.8%	43 66.2%
Patella tracking - lateralized	2 2.9%	0 0%
Patella tracking - subluxation	0 0%	0 0%
Patella tracking - dislocation	0 0%	0 0%
Patella tracking - missing	1 1.5%	0 0%
Fixation - fixation/ingrowth	28 41.2%	24 36.9%
Fixation - x-ray unclear	0 0%	0 0%
Fixation - indifferent, bone unchanged	27 39.7%	24 36.9%
Fixation - increased osseointegration	0 0%	0 0%
Fixation - bone loss	0 0%	0 0%
Fixation - implant at risk	1 1.5%	0 0%
Fixation - implant loosening	0 0%	0 0%
Fixation - revision indication	0 0%	0 0%
Observations - periosteal hypertrophy	0 0%	0 0%
Observations - osteolysis	0 0%	0 0%
Observations - subsidence	0 0%	0 0%
Observations - other	1 1.5%	0 0%
Evidence of deformity - no	45 66.2%	43 66.2%
Evidence of deformity - yes	0 0%	0 0%

9. Secondary Outcome

Title	Evaluation of Health Economic Criteria - Surgical Time Details
Description	Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Time Frame	During and immediately following surgery

Outcome Measure Data

Analysis Population Description

Not all analysis values were available for all enrolled subjects.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	62	60
Anesthesia time	128.8 (37.2)	126.5 (32.8)
Skin to skin time	74.9 (23.5)	75.4 (23.6)
Tray setup time	16.5 (13.9)	19.7 (11.7)
Duration of operation	110.6 (29.5)	110.9 (26.8)

10. Secondary Outcome

Title	Evaluation of Health Economic Criteria - Blood Loss
Description	Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Time Frame	During and immediately following surgery

Outcome Measure Data

Analysis Population Description

Not all analysis values were available for all enrolled subjects.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	62	60
Mean (Standard Deviation) [mL]	105.2 (85.1)	93.8 (39.0)

11. Secondary Outcome

Title	Evaluation of Health Economic Criteria - Incision Length
Description	Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Time Frame	During and immediately following surgery

Outcome Measure Data

Analysis Population Description

Not all analysis values were available for all enrolled subjects.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	61	59
Mean (Standard Deviation) [mm]	153.6 (21.2)	156.8 (18.4)

12. Secondary Outcome

Title	Evaluation of Health Economic Criteria - Instrument Tray Use
Description	Analysis of health data captured during and immediately following surgery: anesthesia time, operative time (skin-to-skin), tray setup, duration of operation, blood loss, incision length, number of instrument trays setup, and number of instrument trays used.
Time Frame	During and immediately following surgery

Outcome Measure Data

Analysis Population Description

Not all analysis values were available for all enrolled subjects.

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	60	59
Instrument trays used in setup	5.3 (4.2)	8.2 (2.6)
Instrument trays used	5.1 (3.8)	8.0 (2.6)

13. Secondary Outcome

Title	Evaluation of Health Economic Surgical Criteria
Description	Analysis of health data captured during and immediately following surgery: surgical approach, cut order, final status of posterior cruciate ligament (PCL), and need for perioperative prophylaxis antibiotics.
Time Frame	During and immediately following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VISIONAIRE Instrumentation	Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.	TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
Measure Participants	62	60
Surgical approach - medial parapatellar	58 85.3%	56 86.2%
Surgical approach - subvastus	0 0%	0 0%
Surgical approach - midvastus	4 5.9%	2 3.1%
Surgical approach - lateral parapatellar	0 0%	1 1.5%
Surgical approach - other	0 0%	1 1.5%
Surgical approach - missing	0 0%	0 0%
Cut order - distal cut first	57 83.8%	46 70.8%
Cut order - anterior cut first	5 7.4%	13 20%
Cut order - tibial cut first	0 0%	1 1.5%
Cut order - missing	0 0%	0 0%
Final status of PCL - excised	29 42.6%	27 41.5%
Final status of PCL - released	2 2.9%	3 4.6%
Final status of PCL - intact	13 19.1%	15 23.1%
Final status of PCL - N/A (PS component used)	18 26.5%	15 23.1%
Final status of PCL - missing	0 0%	0 0%
Perioperative prophylaxis antibiotics - no	0 0%	0 0%
Perioperative prophylaxis antibiotics - yes	62 91.2%	60 92.3%

Adverse Events

Time Frame	The time of operation through 2 years postoperatively.
Arm/Group Title	VISIONAIRE Instrumentation		Standard Instrumentation
Arm/Group Description	TKA with VISIONAIRE instrumentation Total Knee Arthroplasty: TKA was performed with VISIONAIRE instrumentation. Total knee arthroplasty was performed using customized surgical instruments created from preoperative imaging and specialized software, VISIONAIRE Patient-Matched Technology, which was used to match the patient's unique anatomy.		TKA with standard instrumentation Total Knee Arthroplasty was performed using conventional instrumentation.
All Cause Mortality
	VISIONAIRE Instrumentation		Standard Instrumentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/68 (1.5%)		0/66 (0%)
Serious Adverse Events
	VISIONAIRE Instrumentation		Standard Instrumentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	VISIONAIRE Instrumentation		Standard Instrumentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/68 (63.2%)		38/66 (57.6%)
Blood and lymphatic system disorders
Anemia	0/68 (0%)	0	1/66 (1.5%)	1
Vascular calcification, right leg popliteal artery	1/68 (1.5%)	1	0/66 (0%)	0
Bilateral DVT	1/68 (1.5%)	1	0/66 (0%)	0
Pulmonary embolism	1/68 (1.5%)	1	0/66 (0%)	0
Anemia	1/68 (1.5%)	1	0/66 (0%)	0
Thrombophlebitis	1/68 (1.5%)	1	0/66 (0%)	0
DVT secondary to Factor V	0/68 (0%)	0	1/66 (1.5%)	1
Peroneal and gastrocnemius vein clot at mid-calf	1/68 (1.5%)	1	0/66 (0%)	0
Sed rate of 27; reference range 0-15	1/68 (1.5%)	1	0/66 (0%)	0
Follow up for anemia	0/68 (0%)	0	1/66 (1.5%)	1
Acute blood loss anemia s/p surgery, transfusion not required	1/68 (1.5%)	1	0/66 (0%)	0
Cardiac disorders
Chest pain	0/68 (0%)	0	1/66 (1.5%)	2
Arterial blood clots due to mitral valve disease; had a TEE	0/68 (0%)	0	1/66 (1.5%)	2
Atrial fibrillation after elective right TKA	1/68 (1.5%)	3	0/66 (0%)	0
Hypotension	1/68 (1.5%)	1	0/66 (0%)	0
Pericardial effusion	1/68 (1.5%)	1	0/66 (0%)	0
Endocrine disorders
Diabetes	1/68 (1.5%)	1	0/66 (0%)	0
Gastrointestinal disorders
Nausea postoperatively during hospitalization	0/68 (0%)	0	1/66 (1.5%)	1
Gastroenteritis	0/68 (0%)	0	1/66 (1.5%)	1
Bright red blood from rectum and constipation while in hospital	1/68 (1.5%)	1	0/66 (0%)	0
Re-hospitalization for GI bleed and anemia	1/68 (1.5%)	1	0/66 (0%)	0
Constipation	1/68 (1.5%)	1	1/66 (1.5%)	1
Vomiting	0/68 (0%)	0	1/66 (1.5%)	1
Ileus	1/68 (1.5%)	1	0/66 (0%)	0
Gastritis, with gallballder polys, had cholecystectomy	1/68 (1.5%)	2	0/66 (0%)	0
Abdominal pain	1/68 (1.5%)	1	0/66 (0%)	0
Gastroesophageal reflux disease	1/68 (1.5%)	1	0/66 (0%)	0
Blood in stool, suspected hemorrhoid	1/68 (1.5%)	1	0/66 (0%)	0
General disorders
Confusion	0/68 (0%)	0	1/66 (1.5%)	1
Patient reported felt feverish post-op	1/68 (1.5%)	1	0/66 (0%)	0
Syncope	0/68 (0%)	0	1/66 (1.5%)	1
Infections and infestations
Suspected chest infection 1 week post-op	0/68 (0%)	0	1/66 (1.5%)	1
Superficial wound infection	1/68 (1.5%)	1	0/66 (0%)	0
Septic knee	1/68 (1.5%)	1	0/66 (0%)	0
Injury, poisoning and procedural complications
Fall on operated knee resulting in pain	0/68 (0%)	0	1/66 (1.5%)	1
Fall - painful knee and wrist	0/68 (0%)	0	1/66 (1.5%)	1
Right hip fracture	1/68 (1.5%)	1	0/66 (0%)	0
Wound dehiscence/extruded stitches	0/68 (0%)	0	1/66 (1.5%)	1
Patient fell on buttock, increased left knee discomfort	1/68 (1.5%)	1	0/66 (0%)	0
Patient fell and had minor bruising to study knee	1/68 (1.5%)	1	0/66 (0%)	0
Right distal radius fracture	1/68 (1.5%)	1	0/66 (0%)	0
Left distal radius fracture	1/68 (1.5%)	1	0/66 (0%)	0
Fell post-op x2 at home after standing and getting dizzy	0/68 (0%)	0	1/66 (1.5%)	2
Patellar dislocation	0/68 (0%)	0	1/66 (1.5%)	1
Metabolism and nutrition disorders
Weight gain	1/68 (1.5%)	1	0/66 (0%)	0
Hyponatremia	1/68 (1.5%)	1	1/66 (1.5%)	1
Musculoskeletal and connective tissue disorders
Painful, hot, stiff knee post-op	1/68 (1.5%)	1	0/66 (0%)	0
Stiff knee requiring manipulation under anesthesia	0/68 (0%)	0	2/66 (3%)	2
Contralateral TKR	2/68 (2.9%)	2	0/66 (0%)	0
Knee pes tendonitis	1/68 (1.5%)	1	0/66 (0%)	0
Decreased ROM left knee secondary to post-op chest infection, unable to do PT	0/68 (0%)	0	1/66 (1.5%)	1
Low back pain	1/68 (1.5%)	1	0/66 (0%)	0
Left IT band tendonitis	1/68 (1.5%)	1	0/66 (0%)	0
Left knee slight clicking sensation	1/68 (1.5%)	1	0/66 (0%)	0
Medial joint line tenderness with certain twisting maneuvers	1/68 (1.5%)	1	0/66 (0%)	0
Cervical stenosis with cervical DJD	1/68 (1.5%)	1	0/66 (0%)	0
Mild lateral pain by insertion of ITB left study knee	1/68 (1.5%)	1	0/66 (0%)	0
Bilateral thigh pain, left worse than right	1/68 (1.5%)	1	0/66 (0%)	0
Bilateral trochanteric bursitis - hips	1/68 (1.5%)	1	0/66 (0%)	0
Painful left knee	0/68 (0%)	0	1/66 (1.5%)	1
Left knee instability	0/68 (0%)	0	1/66 (1.5%)	1
Low back/hip pain	1/68 (1.5%)	1	0/66 (0%)	0
Persistent knee pain after kneeling on study knee	1/68 (1.5%)	1	0/66 (0%)	0
Pain and discomfort in left knee due to osteoarthritis	0/68 (0%)	0	1/66 (1.5%)	1
Right mid-foot pain requiring cortisone injection	0/68 (0%)	0	1/66 (1.5%)	1
Poor ROM	1/68 (1.5%)	1	0/66 (0%)	0
Pain in left knee	1/68 (1.5%)	1	0/66 (0%)	0
Follow up for poor ROM	1/68 (1.5%)	1	0/66 (0%)	0
Degenerative arthritis, right knee	1/68 (1.5%)	1	0/66 (0%)	0
Osteoarthritis right shoulder	1/68 (1.5%)	1	0/66 (0%)	0
Spinal stenosis	1/68 (1.5%)	1	0/66 (0%)	0
Ischial bursitis on left	1/68 (1.5%)	1	0/66 (0%)	0
Left knee osteoarthritis	0/68 (0%)	0	1/66 (1.5%)	1
Poor ROM right knee	0/68 (0%)	0	1/66 (1.5%)	1
Right knee pain	0/68 (0%)	0	1/66 (1.5%)	2
Joint pain left knee	0/68 (0%)	0	1/66 (1.5%)	1
Knee arthrofibrosis s/p TKA, treated with manipulation	0/68 (0%)	0	1/66 (1.5%)	2
Bilateral leg and foot pain; lumbar degenerative disc disease	0/68 (0%)	0	1/66 (1.5%)	1
Left knee w/ mild pain and crepitance	1/68 (1.5%)	1	0/66 (0%)	0
Degenerative disc disease w/ revision laminectomy	1/68 (1.5%)	1	0/66 (0%)	0
Back pain; dx degenerative disc disease and thoracic sprain	0/68 (0%)	0	1/66 (1.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer of prostate	1/68 (1.5%)	1	0/66 (0%)	0
Brain tumor	0/68 (0%)	0	1/66 (1.5%)	1
Lung cancer	0/68 (0%)	0	1/66 (1.5%)	1
Pancreatic cancer	1/68 (1.5%)	1	0/66 (0%)	0
Nervous system disorders
Carpal tunnel pain with injection	1/68 (1.5%)	1	0/66 (0%)	0
Renal and urinary disorders
Nephrolithiasis	1/68 (1.5%)	1	0/66 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough x2 days	0/68 (0%)	0	1/66 (1.5%)	1
Skin and subcutaneous tissue disorders
Post-op wound inflammation, question of stitch reaction	1/68 (1.5%)	1	0/66 (0%)	0
Wound dehiscence requiring sutures	1/68 (1.5%)	1	0/66 (0%)	0
Moderate effusion requiring aspiration	3/68 (4.4%)	4	0/66 (0%)	0
Moderate effusion	1/68 (1.5%)	1	0/66 (0%)	0
Effusion	0/68 (0%)	0	1/66 (1.5%)	1
Right knee effusion	0/68 (0%)	0	1/66 (1.5%)	1
Left knee effusion	0/68 (0%)	0	1/66 (1.5%)	1
Knee swollen with no erythema	1/68 (1.5%)	1	0/66 (0%)	0
Skin and tissues around knee seem thick and woody	1/68 (1.5%)	1	0/66 (0%)	0
Swelling post-op right leg	0/68 (0%)	0	1/66 (1.5%)	1
Erythema of wound	0/68 (0%)	0	1/66 (1.5%)	1
Right TKA incision tenderness	0/68 (0%)	0	1/66 (1.5%)	1
Surgical and medical procedures
Planned left THA	1/68 (1.5%)	1	0/66 (0%)	0
Left knee arthroscopy	1/68 (1.5%)	1	0/66 (0%)	0
Right total knee arthroplasty	1/68 (1.5%)	1	4/66 (6.1%)	4
Left total knee arthroplasty	1/68 (1.5%)	1	3/66 (4.5%)	3
Left total shoulder replacement	0/68 (0%)	0	1/66 (1.5%)	1
Lumbar laminectomy, fusion of L3-5 and iliac crest bone graft	0/68 (0%)	0	1/66 (1.5%)	1
Heart surgery, insertion of mechanical valve in aorta	0/68 (0%)	0	1/66 (1.5%)	1
Surgery for bladder prolapse, mesh removal	1/68 (1.5%)	1	0/66 (0%)	0
Ascending aortic dissection repair	0/68 (0%)	0	1/66 (1.5%)	1
Chest pain, dx stenosis; catheterization and stent placement	1/68 (1.5%)	1	0/66 (0%)	0
Hernia repair	1/68 (1.5%)	1	0/66 (0%)	0
L5-S1 lumbar epidural steroid injection	1/68 (1.5%)	7	0/66 (0%)	0
Back surgery for back pain	1/68 (1.5%)	1	0/66 (0%)	0
Removal of prosthesis, left unicompartmental knee arthroplasty revision	0/68 (0%)	0	1/66 (1.5%)	1
Appendectomy	0/68 (0%)	0	1/66 (1.5%)	1
Arthroscopic shoulder debridement and biceps tenolysis	1/68 (1.5%)	1	0/66 (0%)	0
Cervical fusion	0/68 (0%)	0	1/66 (1.5%)	1
Whipple procedure	1/68 (1.5%)	1	0/66 (0%)	0
Right carpal tunnel release	0/68 (0%)	0	1/66 (1.5%)	1
Right A1 pulley ganglion cyst aspiration	1/68 (1.5%)	1	0/66 (0%)	0
Cervical disc decompression and fusion	1/68 (1.5%)	1	0/66 (0%)	0
Left knee injection for osteoarthritis	1/68 (1.5%)	1	0/66 (0%)	0
Mild effusion, aspiration performed	1/68 (1.5%)	1	0/66 (0%)	0
Repair of left rotator cuff tear	1/68 (1.5%)	1	0/66 (0%)	0
Left knee arthroscopy	0/68 (0%)	0	1/66 (1.5%)	1
Right knee aspiration due to effusion	0/68 (0%)	0	1/66 (1.5%)	1
Colonoscopy	0/68 (0%)	0	1/66 (1.5%)	1
TKA on contralateral leg	0/68 (0%)	0	1/66 (1.5%)	1

Limitations/Caveats

The major limitation for this study was not reaching the target number of participants needed to achieve target power and statistical analyses leading to uninterpretable data.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.