LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: total knee arthroplasty device.
- Who it may be relevant to
- Registry conditions: Osteoarthritis (OA) of the Knee, Fracture, Rheumatoid Arthritis. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device total knee arthroplasty device
total knee arthroplasty device with ultracongruent bearing surface
Primary outcome measures
- Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline [Time frame: 1 year postoperative]
- Revision rate [Time frame: 5 years postoperative]
Secondary outcome measures (7)
- Knee Society Score - change from baseline [Time frame: postoperative intervals through 5 years]
- PROMIS Global Health Score - change from baseline [Time frame: postoperative intervals through 5 years]
- Surgery Satisfaction Score [Time frame: 1 and 5 years postoperative]
- Forgotten Joint Score [Time frame: postoperative intervals through 5 years]
- Knee Society Roentgenographic Evaluation and Scoring System [Time frame: Through 2 years postoperative]
- PROMIS Pain Interference Score - change from baseline [Time frame: postoperative intervals through 5 years]
- PROMIS Physical Function Score - change from baseline [Time frame: postoperative intervals through 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- OrthoAlabama Spine & Sports — Birmingham
- Illinois Bone and Joint Institute — Libertyville
Identifiers
NCT: NCT06670651 · LB24001-LSKUC