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

Enrolling By InvitationN/A

Sponsor: LinkBio Corp.

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

Interventions: total knee arthroplasty device

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 79 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (2)

Birmingham, Alabama, United States
Libertyville, Illinois, United States