SOLO: ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty

• Sponsor: DePuy Orthopaedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02574312
• Collaborator: (none)
• Enrollment: 88
• Locations: 4
• Arms: 2
• Actual Duration (Months): 41.9
• Patients Per Site: 22
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Post-traumatic Arthritis	Device: ATTUNE TKA with ATTUNE RUI; Device: ATTUNE TKA with ATTUNE SUI	N/A

Detailed Description

This study is designed as comparative, sequential, non-randomized, multi-center investigation.

Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA with single use instruments.

The mechanical axis alignment will be assessed at the 3 month follow-up by independent radiographic review.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Alignment Achieved Using Single-Use Versus Reusable Instrumentation in Total Knee Arthroplasty (TKA): A Prospective, Non-Randomized Multi-center Investigation
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Mar 28, 2019
• Actual Study Completion Date: Mar 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TKA with RUI 44 Subjects will receive TKA with RUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Reusable instruments (RUI).	Device: ATTUNE TKA with ATTUNE RUI; ATTUNE TKA with ATTUNE RUI; Other Names: ATTUNE Intuition
Experimental: TKA with SUI 44 Subjects will receive TKA with SUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Single Use Instruments (SUI).	Device: ATTUNE TKA with ATTUNE SUI; ATTUNE TKA with ATTUNE SUI; Other Names: ATTUNE SOLO

Outcome Measures

Primary Outcome Measures

1. Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation [3 Months Post Surgery]

Secondary Outcome Measures

1. Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation [3 Months Post Surgery]

2. Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation [3 Months Post Surgery]

3. Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation [3 Months Post Surgery]

4. Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation [3 Months Post Surgery]

5. Number of Participants With Treatment-related Adverse Events [3 Months Post Surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post-traumatic arthritis.

2. Subject is male or female and between the ages of 22 and 80 years old, inclusive.

3. Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.

4. Subject, who, in the opinion of the Investigator, is suitable for implantation using either RUI or SUI instrumentation.

5. Subject is able to speak and read English to facilitate comprehension of the Informed Consent Document.

6. Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy Synthes Joint Reconstruction.

7. Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures.

Exclusion Criteria:

1. The Subject has, in the opinion of the Investigator, a severe deformity that will hinder achieving a mechanical axis alignment target of 0° ± 3°.

2. The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.

3. The Subject has, in the opinion of the Investigator, a flexion deformity that will not allow for 0° extension postoperatively.

4. The Subject is a woman who is pregnant or lactating.

5. The Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect follow-up care or treatment outcomes.

6. The Subject has participated in a clinical investigation with an investigational product in the last 3 months.

7. The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.

8. The Subject has previous prosthetic knee replacement (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty or ipsilateral UTO/HTO) of the affected knee or a previous patellectomy.

9. The Subject presents with ankylosis of the hip joint on the side to be treated.

10. The Subject had a contralateral TKA and that knee was previously entered into the study.

11. The Subject requires simultaneous bilateral total knee replacements.

12. Any case in which Computer-Assisted Surgery (CAS) or TruMatch (or any other type of Custom Patient Instruments) is to be used, or any additional instrumentation are to be used for bone resections that are not provided as part of the ATTUNE RUI or SUI Instrument kits.

13. The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Clinic Torrey Pines	La Jolla	California	United States	92037
2	Geisinger Wyoming Valley	Wilkes-Barre	Pennsylvania	United States	18702
3	Spire Liverpool Hospital	Liverpool		United Kingdom	L18 1HQ
4	Clifton Park Hospital	York		United Kingdom	YO30 5RA

Sponsors and Collaborators

• DePuy Orthopaedics

Investigators

• Study Director: Verdonna Huey, MS,BSN,CCRP, DePuy Synthes

Study Documents (Full-Text)

• Study Protocol - Feb 19, 2018
• Statistical Analysis Plan - May 6, 2019

More Information

Publications

None provided.

• Responsible Party: DePuy Orthopaedics
• ClinicalTrials.gov Identifier: NCT02574312
• Other Study ID Numbers: 10002
• First Posted: Oct 12, 2015
• Last Update Posted: Apr 9, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by DePuy Orthopaedics: Mechanical Axis Alignment; Knee Arthroplasty, Total
• Additional relevant MeSH terms: Osteoarthritis

Study Results

Participant Flow

Recruitment Details	The first patient was operated on 16 November 2015 and recruitment lasted for 37 months with the last patient operated on 19 December 2018.
Pre-assignment Detail	Consent was taken for 102 knees, 14 subjects were deemed ineligible for the study. This left 88 subjects in the safety population that could be randomised for the study.

Arm/Group Title	RUI (Reuseable Instrumentation)	SUI (Single-Use Instrumentation)
Arm/Group Description	Patients were operated on using Reusable TKA Instrumentation	Patients were operated on using Single-Use TKA Instrumentation
Period Title: Pre-Operative
STARTED	44	44
COMPLETED	44	44
NOT COMPLETED	0	0
Period Title: Pre-Operative
STARTED	44	44
COMPLETED	43	44
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	RUI (Reuseable Instrumentation)	SUI (Single-Use Instrumentation)	Total
Arm/Group Description	Patients were operated on using Reusable TKA Instrumentation	Patients were operated on using Single-Use TKA Instrumentation	Total of all reporting groups
Overall Participants	44	44	88
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.0 (6.89)	69.3 (7.98)	67.9 (8.0)
Sex: Female, Male (Count of Participants)
Female	20 45.5%	26 59.1%	46 52.3%
Male	24 54.5%	18 40.9%	42 47.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	22 50%	22 50%	44 50%
Unknown or Not Reported	22 50%	22 50%	44 50%
Region of Enrollment (Count of Participants)
United Kingdom	22 50%	22 50%	44 50%
United States	22 50%	22 50%	44 50%

Outcome Measures

1. Primary Outcome

Title	Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Time Frame	3 Months Post Surgery

Outcome Measure Data

Analysis Population Description

All patients with readable radiographs who were enrolled without major protocol violations

Arm/Group Title	RUI (Reuseable Instrumentation)	SUI (Single-Use Instrumentation)
Arm/Group Description	Patients were operated on using Reusable TKA Instrumentation	Patients were operated on using Single-Use TKA Instrumentation
Measure Participants	34	41
Measure Radiographs	34	41
Mean (Standard Deviation) [Degrees]	2.55 (2.44)	2.97 (2.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RUI (Reuseable Instrumentation), SUI (Single-Use Instrumentation)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-Inferiority Analysis of absolute value of mechanical axis alignment with NI margin of 1.5 degrees, using a 1-sided T-test with alpha of 0.05. Anticipated power was 95%.
Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	t-test, 1 sided
	Comments

2. Secondary Outcome

Title	Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Time Frame	3 Months Post Surgery

Outcome Measure Data

Analysis Population Description

All patients with readable radiographs who were enrolled without major protocol violations

Arm/Group Title	RUI (Reuseable Instrumentation)	SUI (Single-Use Instrumentation)
Arm/Group Description	Patients were operated on using Reusable TKA Instrumentation	Patients were operated on using Single-Use TKA Instrumentation
Measure Participants	34	41
Measure Radiographs	34	41
Mean (Standard Deviation) [Degrees]	94.9 (2.10)	95.8 (2.40)

3. Secondary Outcome

Title	Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Time Frame	3 Months Post Surgery

Outcome Measure Data

Analysis Population Description

All patients with readable radiographs who were enrolled without major protocol violations

Arm/Group Title	RUI (Reuseable Instrumentation)	SUI (Single-Use Instrumentation)
Arm/Group Description	Patients were operated on using Reusable TKA Instrumentation	Patients were operated on using Single-Use TKA Instrumentation
Measure Participants	34	41
Measure Radiographs	34	41
Mean (Standard Deviation) [Degrees]	88.4 (2.18)	88.7 (2.23)

4. Secondary Outcome

Title	Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation
Time Frame	3 Months Post Surgery

Outcome Measure Data

Analysis Population Description

All patients with readable radiographs who were enrolled without major protocol violations

Arm/Group Title	RUI (Reuseable Instrumentation)	SUI (Single-Use Instrumentation)
Arm/Group Description	Patients were operated on using Reusable TKA Instrumentation	Patients were operated on using Single-Use TKA Instrumentation
Measure Participants	34	41
Measure Radiographs	34	41
Mean (Standard Deviation) [Degrees]	6.21 (2.70)	7.91 (3.20)

5. Secondary Outcome

Title	Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation
Time Frame	3 Months Post Surgery

Outcome Measure Data

Analysis Population Description

All patients with readable radiographs who were enrolled without major protocol violations

Arm/Group Title	RUI (Reuseable Instrumentation)	SUI (Single-Use Instrumentation)
Arm/Group Description	Patients were operated on using Reusable TKA Instrumentation	Patients were operated on using Single-Use TKA Instrumentation
Measure Participants	34	41
Measure Radiographs	34	41
Mean (Standard Deviation) [Degrees]	1.04 (2.49)	0.78 (2.70)

6. Secondary Outcome

Title	Number of Participants With Treatment-related Adverse Events
Time Frame	3 Months Post Surgery

Outcome Measure Data

Analysis Population Description

All subjects who received the study device

Arm/Group Title	RUI (Reuseable Instrumentation)	SUI (Single-Use Instrumentation)
Arm/Group Description	Patients were operated on using Reusable TKA Instrumentation	Patients were operated on using Single-Use TKA Instrumentation
Measure Participants	44	44
Number [Participants]	0 0%	0 0%

Adverse Events

Time Frame	All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Adverse Event Reporting Description	Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
Arm/Group Title	RUI (Reuseable Instrumentation)		SUI (Single-Use Instrumentation)
Arm/Group Description	Patients were operated on using Reusable TKA Instrumentation		Patients were operated on using Single-Use TKA Instrumentation
All Cause Mortality
	RUI (Reuseable Instrumentation)		SUI (Single-Use Instrumentation)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Serious Adverse Events
	RUI (Reuseable Instrumentation)		SUI (Single-Use Instrumentation)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/44 (2.3%)		0/44 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal	1/44 (2.3%)	1	0/44 (0%)	0
Other (Not Including Serious) Adverse Events
	RUI (Reuseable Instrumentation)		SUI (Single-Use Instrumentation)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/44 (11.4%)		2/44 (4.5%)
Immune system disorders
Immune System Disorder	1/44 (2.3%)	1	0/44 (0%)	0
Infections and infestations
Infections and infestations	1/44 (2.3%)	1	1/44 (2.3%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal	2/44 (4.5%)	2	2/44 (4.5%)	2
Vascular disorders
Vascular	1/44 (2.3%)	1	0/44 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

DePuy reserves the right to review the contents of publications in advance.The PI may freely disclose the trial results only after DePuy has been given the opportunity of reviewing the proposed results communications at least 30 days prior to the intended release.DePuy will advise the PI of any perceived errors,omissions or corrections but PI will retain final editorial control. In case of disagreement, DePuy and PI will make every effort to meet in order to discuss and resolve any issues.