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

N/AEnrolling By InvitationNCT06670651

LinkBio Corp.600 enrolled

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.

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Osteoarthritis (OA) of the Knee Fracture Rheumatoid Arthritis

Interventions

total knee arthroplasty deviceDEVICE

total knee arthroplasty device with ultracongruent bearing surface

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (2)

OrthoAlabama Spine & Sports

Birmingham, Alabama, United States

Illinois Bone and Joint Institute

Libertyville, Illinois, United States

Outcomes

Primary Outcomes

Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) - change from baseline

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.

Time frame: 1 year postoperative

Revision rate

Evaluates how often patients require additional surgery to remove or replace the knee arthroplasty device components.

Time frame: 5 years postoperative

Secondary Outcomes

Knee Society Score - change from baseline

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.

Time frame: postoperative intervals through 5 years

PROMIS Global Health Score - change from baseline

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.

Time frame: postoperative intervals through 5 years

Surgery Satisfaction Score

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.

Time frame: 1 and 5 years postoperative

Forgotten Joint Score

Measures a patient's awareness of their artificial knee joint. Minimum score is 0. Maximum score is 100. Higher score means better outcome.

Data from ClinicalTrials.gov

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