WithdrawnNot Applicable

Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective and Clinical Outcome Study

Stopped: Alternate Research Pursued

United States0Started 2016-02

Plain-language summary

To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a primary UKA on the opposite side and are at a minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along with all retrospective chart data.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
✓. Ability to understand and provide written authorization for use and disclosure of personal health information
✓. Subject who are able and willing to comply with the study protocol and follow-up visit
✓. Must be 18 years or older to participate
✓. Subjects must have a clinically documented osteoarthritis in both knees, single or multiple compartments
✓. Subjects must have undergone a primary TKA and primary UKA in the contralateral knee
✓. Must be a minimum 2 year (24 months) post-surgery on each knee
✓. One or both TKA/UKA surgeries must have been performed by the Principal Investigator.

Exclusion criteria

✕. Subjects who underwent UKA with Patella Femoral Joint (PFJ) replacement on the same side.
✕. Women who are pregnant

What they're measuring

To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)

Timeframe: Minimum 2 years post surgery

Trial details

NCT IDNCT02583113

SponsorMedacta USA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-01

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