By InvitationNot Applicable

Oxford UKA and HTO Post-market Clinical Study

China370 participantsStarted 2021-04-24

Plain-language summary

The purpose of this study is to compare the performance and safety of medial UKA and HTO in the treatment of AMOA in term of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patient is aged 18 to 85 years old, inclusive;
✓. Patients who diagnosed with AMOA of the knee, and have undergone Open Wedge HTO, or primary unilateral partial knee arthroplasty with Oxford Partial Knee with Microplasty® instrumentation in accordance to indications of UKA and the following radiographic assessments in the knee joint:
✓. UKA or HTO procedure completed one year prior to study participation;
✓. Patient provides written informed consent by signing and dating the Institutional Review Board/Ethics Committee (IRB/EC) approved informed consent form.

Exclusion criteria

✕. Has undergone UKA but met any of the contraindications included in the product labeling of Oxford Partial Knee system;
✕. Has rheumatoid arthritis or other forms of inflammatory joint disease;
✕. Uncooperative or with neurologic disorders who are incapable of following directions;
✕. Has a diagnosed systemic disease that could affect his/her safety or the study outcome;
✕. Anterior cruciate ligament and posterior cruciate ligament injury, collateral ligament instability;
✕. Known to be pregnant;
✕. Prisoner or known alcohol / drug abuser.

What they're measuring

Oxford Knee Score

Timeframe: 2 years

Trial details

NCT IDNCT04518111

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Knee Osteoarthritis trials