LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis (OA) of the Knee
- Sponsor
- LinkBio Corp.
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline
- Status
- Enrolling By Invitation
- Last Updated
- 10 months ago
Overview
Brief Summary
To collect information about implant performance and patient clinical outcomes in patients undergoing primary total knee arthroplasty with the LinkSymphoKnee total knee replacement system with ultra-congruent tibial bearing surface.
Detailed Description
The study will collect outcomes data on up to 600 patients from up to 3 sites using a legally marketed device according to its labeled intended use. The study will collect: 1. KOOS-JR 2. Knee Society Score (KSS), 2011 3. PROMIS Global Health 4. PROMIS Physical Function 5. PROMIS Pain Interference 6. Surgery Satisfaction 7. Forgotten Joint Score 8. Radiographic findings 9. Revisions. Radiographic evaluations will be done through postoperative year 2. Other outcomes will be evaluated up to postoperative year 5.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years or older, and skeletally mature; and
- •Undergoing a primary TKA for one or both knees using the cemented LinkSymphoKnee knee system as part of the surgeon's standard of care.
- •Able to read and understand English (because patient-reported outcome questionnaires are not validated for all potential other languages).
Exclusion Criteria
- •80 years of age or older,
- •Women who are pregnant at the time of surgery,
- •History of joint sepsis,
- •Bone defect that requires grafting,
- •Previous history of bone disease (e.g., severe osteoporosis or osteomalacia) which in the surgeon's opinion is severe enough to compromise device fixation,
- •Systemic conditions affecting bone density (e.g., inflammatory arthritis or renal disease) which in the surgeon's opinion are severe enough to compromise device fixation,
- •A poorly functioning contralateral total knee replacement or a contralateral revision regardless of function.
Outcomes
Primary Outcomes
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline
Time Frame: 1 year postoperative
Patient-reported outcome measure (PROM) that assesses knee health based on questions about pain, stiffness, function, and daily activities. Minimum score = 0. Maximum score = 100. Higher score means a better outcome.
Revision rate
Time Frame: 5 years postoperative
Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.
Secondary Outcomes
- Knee Society Score - change from baseline(postoperative intervals through 5 years)
- PROMIS Global Health Score - change from baseline(postoperative intervals through 5 years)
- Surgery Satisfaction Score(1 and 5 years postoperative)
- Forgotten Joint Score(postoperative intervals through 5 years)
- Knee Society Roentgenographic Evaluation and Scoring System(Through 2 years postoperative)
- PROMIS Pain Interference Score - change from baseline(postoperative intervals through 5 years)
- PROMIS Physical Function Score - change from baseline(postoperative intervals through 5 years)