ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

Not Applicable

Active, not recruiting

• Conditions: Revision Total Knee Arthroplasty

• Registration Number: NCT03153475
• Lead Sponsor: DePuy Orthopaedics

Brief Summary

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.

Detailed Description

The study is designed as a non-comparative, worldwide, multi-center study with up to 30 sites that will intend to implant a total of 400 Subjects (200 PS RP and 200 PS FB) with the study devices. The follow-up period of 5 years was selected to cover both the early post-operative period as well as the medium term period which is a good indicator of longer term survivorship.

The primary endpoint of survivorship at 5 years was selected to capture the time period during which the majority of revision failures occur while providing a good indication of long term survivorship. The secondary outcomes include commonly used measures of clinical performance that will allow for comparison with published literature. Additionally, patient reported outcomes, AORI bone defect classification , satisfaction and pain scores will be collected and analyzed.

Male and female Subjects, age 22-80 years, inclusive, with a failed primary knee arthroplasty, including unicompartmental or failed previous revision TKA, who are suitable candidates for revision TKA using the ATTUNE® Revision system are eligible for enrollment in this study. The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the second stage within a two-stage treatment for infection.

Study Timeline

• Study First Submitted: 2017-05-07
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Study Start: 2017-05-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-30
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

1. The Subject is a woman who is pregnant or lactating.
2. Contralateral knee has already been enrolled in this study.
3. Subject had a contralateral amputation.
4. Subject is currently diagnosed with radicular pain from the spine that radiates into the limb to receive RTKA.
5. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months.
6. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
7. 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 his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.
8. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
9. Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
10. Subject has a medical condition with less than five (5) years life expectancy as determined by the Investigator.
11. Uncontrolled gout

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Survivorship	5 Years	To evaluate the 5 year survivorship using Kaplan-Meier survival analysis, with revision for any reason as the endpoint, for the ATTUNE® Revision TKA PS FB and PS RP configurations.

Secondary Outcome Measures

Name	Time	Method
Tibial component alignment	1, 2 and 5 years	Evaluate any changes in tibial component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
Patient's Knee Implant Performance (PKIP)	Baseline, 2 and 5 yr timepoints	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes, satisfaction and quality of life assessments, as measured using the PKIP patient reported outcome measure (overalll and subscores)
American Knee Society Score	Baseline, 2 year, 5 year	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, patient satisfaction and expectations and clinical evaluations as measured using the AKS measure
Survivorship	1, 2, 3 and 4 years	Evaluate survivorship of the ATTUNE® Revision TKA system for the PS FB and PS RP configurations and the combined PS FB and PS RP configurations using Kaplan-Meier survival analysis at 1, 2, 3, and 4 years.
Frequency of radiolucent line occurrence	1, 2 and 5 years	Evaluate ATTUNE® Revision TKA fixation through zonal radiographic analysis of the bone-implant interface at 1, 2 and 5 years after surgery compared to the first postoperative radiographs.
Restoration of joint line	First post-operative radiograph (1 day)	Radiographically evaluate the restoration of joint line using the first postoperative radiographs according to the methodology of Figgie.
Adverse Events	Intraoperative, 6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs.	Evaluate type and frequency of Adverse Events
Anatomic Tibiofemoral Alignment	1, 2 and 5 years	Evaluate any changes in anatomic tibiofemoral alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.
EQ-5D-5L	Baseline, 2 year and 5 year	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the EQ-5D-5L patient reported outcome measures
VAS Pain Score	Baseline, 2 year and 5 year	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported pain severity as measured using a modified VAS Pain Score (discrete numbers rather than a continual scale).
Knee Injury and Osteoarthritis Outcome Score Short form (KOOS-PS)	Baseline, 2 year and 5 Year	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in functional outcomes assessments, as measured using the KOOS-PS patient reported outcome measures
Patient Satisfaction	Baseline, 2 year and 5 year	Evaluate change from preoperative baseline to 2 and 5 yr timepoints in patient reported satisfaction as measured using a Likert scale.
Readmissions	6 weeks, 1 yr, 2 yrs., 3 yrs., 4 yrs., 5 yrs	Evaluate the timing, duration and reason for any readmissions stratified by adverse event type (operative site vs. systemic).
femoral component alignment	1, 2 and 5 years	Evaluate any changes in femoral component alignment at 1, 2 and 5 yrs compared to the first postoperative radiographs.

Trial Locations

Locations (38)

Scripps Clinic Torrey Pines; 🇺🇸 San Diego, California, United States

Colorado Joint Replacement; 🇺🇸 Denver, Colorado, United States

Orthopaedic Center of the Rockies; 🇺🇸 Fort Collins, Colorado, United States

Orthopedic Partners; 🇺🇸 Niantic, Connecticut, United States

Florida Orthopedic Associates; 🇺🇸 DeLand, Florida, United States

Arthroplasty Foundation; 🇺🇸 Louisville, Kentucky, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Mery Hospital; 🇺🇸 Ozark, Missouri, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Rothman Institute; 🇺🇸 Egg Harbor Township, New Jersey, United States

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