LinkSymphoKnee (LSK) Total Knee Replacement System Study - Ultra-congruent (UC)

• Conditions: Osteoarthritis (OA) of the Knee; Fracture; Rheumatoid Arthritis

• Registration Number: NCT06670651
• Lead Sponsor: LinkBio Corp.

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.

Study Timeline

• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-01
• Study Start: 2025-03-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Primary Completion: 2031-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline	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	5 years postoperative	Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.

Secondary Outcome Measures

Name	Time	Method
Knee Society Score - change from baseline	postoperative intervals through 5 years	A rating scale that measures the outcome of a patient's knee replacement surgery by assessing objective and subjective outcomes, including pain, range of motion, stability, walking distance, and ability to climb stairs, and also patient satisfaction and expectations. Minimum score = 0. Maximum score = 100. Higher score means better outcome.
PROMIS Global Health Score - change from baseline	postoperative intervals through 5 years	PROMIS Global Health measures physical function, pain, fatigue, emotional distress, and social health. The raw score minimum is 7 and maximum is 35. Higher score means better outcome.
Surgery Satisfaction Score	1 and 5 years postoperative	Measures a patient's satisfaction with a surgical procedure based on questions about pain control and daily activities. Minimum score is 0. Maximum score is 10. Higher score means better outcome.
Forgotten Joint Score	postoperative intervals through 5 years	Measures a patient's awareness of their artificial knee joint. Minimum score is 0. Maximum score is 100. Higher score means better outcome.
Knee Society Roentgenographic Evaluation and Scoring System	Through 2 years postoperative	Evaluates radiographic signs of device stability. 3 zones are assigned to evaluate the patella component. 5-7 zones are assigned to evaluate the tibia and femur components. Radiolucencies are evaluated for size, location, and progression over time. Changes in implant position and/or radiolucencies that are large, continuous, or progressive over time signify possible or impending implant failure.
PROMIS Pain Interference Score - change from baseline	postoperative intervals through 5 years	The score measures how pain affects a person's life. The raw score minimum is 6 and maximum is 30. A lower score means a better outcome.
PROMIS Physical Function Score - change from baseline	postoperative intervals through 5 years	The score measures a person's ability to perform activities. The raw score minimum is 11 and maximum is 72.5. A higher score means a better outcome.

Trial Locations

Locations (3)

OrthoAlabama Spine & Sports; 🇺🇸 Birmingham, Alabama, United States

Illinois Bone and Joint Institute; 🇺🇸 Libertyville, Illinois, United States

Indiana Joint Replacement Institute; 🇺🇸 Noblesville, Indiana, United States