Clinical trial NCT06670651: LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
Official title: LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Osteoarthritis (OA) of the Knee
Fracture
Rheumatoid Arthritis
Keywords: primary total knee arthroplasty
Lead sponsor: LinkBio Corp.
Sponsor class: INDUSTRY
First posted: 2024-11-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seeking primary total knee arthroplasty from the participating surgeon investigators

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.

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.

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline
timeFrame: 1 year postoperative
measure: Revision rate
timeFrame: 5 years postoperative
Secondary outcomes:
measure: Knee Society Score - change from baseline
timeFrame: postoperative intervals through 5 years
measure: PROMIS Global Health Score - change from baseline
timeFrame: postoperative intervals through 5 years
measure: Surgery Satisfaction Score
timeFrame: 1 and 5 years postoperative
measure: Forgotten Joint Score
timeFrame: postoperative intervals through 5 years
measure: Knee Society Roentgenographic Evaluation and Scoring System
timeFrame: Through 2 years postoperative
measure: PROMIS Pain Interference Score - change from baseline
timeFrame: postoperative intervals through 5 years
measure: PROMIS Physical Function Score - change from baseline
timeFrame: postoperative intervals through 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: OrthoAlabama Spine & Sports
state: Alabama
city: Libertyville
country: United States
facility: Illinois Bone and Joint Institute
state: Illinois
Study officials:
affiliation: Illinois Bone & Joint Institute
name: Brian Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: