Robotic Arm Assisted Total Knee Arthroplasty

• Sponsor: MAKO Surgical Corp. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02058069
• Collaborator: (none)
• Enrollment: 100
• Locations: 3
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 33.3
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB).

The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application.

Specifically, the study objectives are classified as follows:

• Primary Objective: Surgeon assessment of standardized TKA complications both intra-operatively and at short term follow up.

• Secondary Objective: Radiographic assessment of post-operative limb alignment.

• Supporting Objective: Patient assessment of post-operative function and satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis	Device: Robotic Arm Assisted Total Knee Arthroplasty	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Robotic Arm Assisted Total Knee Arthroplasty
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robotic Assisted Total Knee Arthroplasty	Device: Robotic Arm Assisted Total Knee Arthroplasty; The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).; Other Names: MAKO Surgical Corp RIO Total Knee Arthroplasty Application MAKOplasty Total Knee Arthroplasty

Outcome Measures

Primary Outcome Measures

1. Intra-Operative Complications [Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.]

   Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.

2. Intra-Operative Complications [Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.]

   Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.

3. Intra-Operative Complications [3 Month Post Op]

   Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.

Secondary Outcome Measures

1. Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative [pre-op plan, 3 Month Post Op]

   Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.

2. Participants With Limb Alignment Difference <4.38 Degrees [Pre-op Plan, 3 Month Post Op]

   The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference <4.38 was considered a success; >4.38 degrees was considered a failure.

Other Outcome Measures

1. Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) [Pre-Op, 3 Month Post Op [change assessed between the two time periods]]

   The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes. The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female subjects may be recruited in to the Investigation.

• Age - The subject must be at least 21 years of age and skeletally mature as demonstrated radiographically by complete closure of the distal femoral and proximal tibial epiphyses.

• Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

• Subjects who, in the opinion of the Investigators and Approved Study Staff, are able to understand this Investigation and cooperate with the Investigation procedures and are willing to comply with all the required post-operative follow-ups.

• Subjects who require a total knee arthroplasty for primary surgical management of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, moderate deformities or femoral condyle osteonecrosis as defined below.

• Osteoarthritis: Kellgren-Lawrence Grade 3 or higher, with clinical history of an absence of major trauma to the joint; symptoms of pain, stiffness, swelling, and/or loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral sclerosis, or peripheral osteophytes.

• Post-Traumatic Arthritis: Kellgren-Lawrence Grade 3 or higher, with a clinical history of trauma to the targeted knee and subsequent pain, stiffness, swelling and loss of motion; and with radiographic evidence of joint space narrowing, sub-chondral sclerosis, or peripheral osteophytes.

• Rheumatoid Arthritis: American College of Rheumatology classification score of 6 or higher, with a clinical history that demonstrates the following: morning stiffness for at least 1 hour and present for at least 6 weeks, swelling, loss of motion, and/or serum rheumatoid factor; and radiographic findings of narrow joint space, peri-articular osteopenia, and/or per-articular erosions.

• Moderate Deformities: Moderate varus, valgus, flexion, or post-traumatic deformities of no more than 15° assessed radiographically. Moderate recurvatum of no more than 8° assessed radiographically.

• Femoral Condyle Osteonecrosis: Loss of blood supply in the femoral condyle characterized by sudden onset of pain, possibly triggered by a specific seemingly routine activity or minor injury. Pain is often increased with activity and at night time and may cause swelling of the knee and sensitivity to touch and pressure and may result in limited motion. Confirmed by a bone scan, MRI, and/or x-ray.

• Subjects whose anatomy is appropriate for the available range of implant sizes.

Exclusion Criteria:

• Patients who have had previous surgical procedures requiring implantation of hardware in their operative side knee, hip, or ankle that would result in metal artifact scatter in a CT scan.

• Patients who have a fracture malunion of the distal femur or proximal tibia within 12cm of the knee center, assessed radiographically.

• Patients who are pregnant, may become pregnant during the course of the Investigation, or are currently lactating.

• Patients with allergies or suspected sensitivity to any patient-contacting component of the investigational device or the implant to be used in the study as listed below:

• Femoral component: Cobalt Chromium alloy (CoCr)

• Tibial component: Titanium alloy (Ti6Al4V)

• Tibial inserts and patella component: Vitamin E infused ultra-high molecular weight polyethylene (UHMWPE)

• Saw blade: 440C Stainless Steel

• Patients who require bilateral total knee arthroplasty.

• Patients who are currently on medical leave from their employment due to Workmen's Compensation.

• Patients who are currently state or federal prisoners.

• Patients who are currently Wards of the state.

• Patients who are at high risk for poor healing or confounding outcomes or at excessive risk for surgery i.e.: clinically significant/being actively treated for renal, hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes (HbA1c > 10 mg/dL) or previous history of joint infection.

• Patients who are known drug or alcohol abusers or with psychological disorders as defined by DSM V that could affect follow-up care or treatment outcomes.

• Patients who are currently involved in another clinical study with an investigational device.

• Patients with current litigation pending related to medical treatment of any sort.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coon Joint Replacement Institue; St. Helena Hospital	St. Helena	California	United States	94574
2	Florida Orthopedic Institute	Tampa	Florida	United States	33637
3	Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical Center	Houston	Texas	United States	77024

Sponsors and Collaborators

• MAKO Surgical Corp.

Investigators

• Principal Investigator: Kenneth Gustke, MD, Florida Orthopedic Institute, Tampa General Hospital
• Principal Investigator: Thomas Coon, MD, Coon Joint Replacement Institute, St. Helena Hospital
• Principal Investigator: Stefan Kreuzer, MD, Memorial Bone and Joint Research Foundation, Memorial Hermann Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MAKO Surgical Corp.
• ClinicalTrials.gov Identifier: NCT02058069
• Other Study ID Numbers: RIOTKA_2014; 20131148
• First Posted: Feb 7, 2014
• Last Update Posted: Apr 18, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Arthritis

Study Results

Participant Flow

Arm/Group Title	Robotic Assisted Total Knee Arthroplasty
Arm/Group Description	Participants who underwent primary total knee arthroplasty using the Mako robotic arm system. "Participants" throughout this posting is equivalent to the number of knees.
Period Title: Overall Study
STARTED	100
COMPLETED	89
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Robotic Assisted Total Knee Arthroplasty
Arm/Group Description	Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
Overall Participants	89
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.78 (8.49)
Sex: Female, Male (Count of Participants)
Female	49 55.1%
Male	40 44.9%

Outcome Measures

1. Primary Outcome

Title	Intra-Operative Complications
Description	Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Time Frame	Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.

Outcome Measure Data

Analysis Population Description

participants = knees.

Arm/Group Title	Robotic Assisted Total Knee Arthroplasty
Arm/Group Description	Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
Measure Participants	89
Number [intra-operative complications]	0

2. Primary Outcome

Title	Intra-Operative Complications
Description	Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Time Frame	Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.

Outcome Measure Data

Analysis Population Description

participants = knees.

Arm/Group Title	Robotic Assisted Total Knee Arthroplasty
Arm/Group Description	Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
Measure Participants	89
Number [intra-operative complications]	0

3. Primary Outcome

Title	Intra-Operative Complications
Description	Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.
Time Frame	3 Month Post Op

Outcome Measure Data

Analysis Population Description

participants = knees.

Arm/Group Title	Robotic Assisted Total Knee Arthroplasty
Arm/Group Description	Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
Measure Participants	89
Number [intra-operative complications]	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Robotic Assisted Total Knee Arthroplasty
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The Alternative Hypothesis: The Investigational Device (RIO) true event rate is non-inferior to 0.066 (event rate for manual TKA) with a non-inferiority margin of 0.06. The 0.066 rate is based on literature and 0.06 was determined in consultation with FDA.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Rare Adverse Event Rate
	Estimated Value	0
	Confidence Interval	(1-Sided) 95%; to 0.0331
	Parameter Dispersion	Type: Value:
	Estimation Comments	If the upper bound is <0.126 then the primary composite safety endpoint is met. After the surgeon completed the procedure, at the conclusion of the participant's hospital stay, and 3 months post-operative were used in this single analysis.

4. Secondary Outcome

Title	Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative
Description	Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.
Time Frame	pre-op plan, 3 Month Post Op

Outcome Measure Data

Analysis Population Description

Of the 89 patients who received a robotic assisted total knee arthroplasty as part of the IDE, 2 patients were excluded from analysis for the Secondary Endpoint only due to issues related to the accurate measurement of limb alignment from the radiographs available (not for reasons involving the surgical procedure or clinical outcomes).

Arm/Group Title	Robotic Assisted Total Knee Arthroplasty
Arm/Group Description	Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
Measure Participants	87
Mean (Standard Deviation) [degrees]	1.54 (1.01)

5. Secondary Outcome

Title	Participants With Limb Alignment Difference <4.38 Degrees
Description	The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference <4.38 was considered a success; >4.38 degrees was considered a failure.
Time Frame	Pre-op Plan, 3 Month Post Op

Outcome Measure Data

Analysis Population Description

Participants = knees

Arm/Group Title	Robotic Assisted Total Knee Arthroplasty
Arm/Group Description	Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
Measure Participants	87
Count of Participants [Participants]	87 97.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Robotic Assisted Total Knee Arthroplasty
	Comments
	Type of Statistical Test	Other
	Comments	The analysis was performed using standard OC curves generated using Sample Size Analyzer® version 2.0 by Taylor Enterprise Inc. (Dr. Wayne A. Taylor).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Alignment Difference <4.38 Degrees
	Estimated Value	1
	Confidence Interval	(1-Sided) 95%; 0.966 to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Estimation Parameter is: proportion of participants with limb alignment difference <4.38 degrees If the lower bound is >0.95 then the assessment passes.

6. Other Pre-specified Outcome

Title	Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
Description	The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes. The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment.
Time Frame	Pre-Op, 3 Month Post Op [change assessed between the two time periods]

Outcome Measure Data

Analysis Population Description

participants = knees.

Arm/Group Title	Robotic Assisted Total Knee Arthroplasty
Arm/Group Description	Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
Measure Participants	89
Mean (Standard Deviation) [units on a scale]	-33.1 (20.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Robotic Assisted Total Knee Arthroplasty
	Comments	Change from pre-op to 3 months
	Type of Statistical Test	Non-Inferiority
	Comments	The upper bound for the one-sided 95% confidence interval will be compared with -9. If the upper bound is less than -9, then non-inferiority holds.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-33.1
	Confidence Interval	(1-Sided) 95%; to -29.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	If the upper bound is less than -9, then non-inferiority holds.

Adverse Events

Time Frame	Subject enrollment to end of study.
Adverse Event Reporting Description	Participants = knees
Arm/Group Title	Robotic Assisted Total Knee Arthroplasty
Arm/Group Description	Participants who underwent primary total knee arthroplasty using the Mako robotic arm system. Note regarding serious AEs: Adhesions and arthrofibrosis are surgical complications that can result from knee surgery and present as stiffness and restriction of ROM. Reasons for stiffness and restriction of ROM after TKA are multifactorial and may be influenced by factors such as the patient's overall health, motivation, and compliance to their rehabilitation regimen. The Principal Investigator and study Investigators stated these adverse events are not related to the use of the Investigational Device.
All Cause Mortality
	Robotic Assisted Total Knee Arthroplasty
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Robotic Assisted Total Knee Arthroplasty
	Affected / at Risk (%)	# Events
Total	9/100 (9%)
Musculoskeletal and connective tissue disorders
Arthrofibrosis	4/100 (4%)
Adhesions	4/100 (4%)
Vascular disorders
Pulmonary Embolism	1/100 (1%)
Other (Not Including Serious) Adverse Events
	Robotic Assisted Total Knee Arthroplasty
	Affected / at Risk (%)	# Events
Total	0/100 (0%)

Limitations/Caveats

[Not Specified]

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.