Status:
ENROLLING_BY_INVITATION
Oxford UKA and HTO Post-market Clinical Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-85 years
Brief 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...
Detailed Description
The purpose of this study is to compare the outcomes of medial UKA and HTO in the treatment of AMOA by investigating the performance of these 2 procedures in terms of functional outcome, radiographic ...
Eligibility Criteria
Inclusion
- 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:
- exposed bone on both the femur and tibia in the medial compartment.
- functionally intact ACL
- full thickness lateral cartilage (ignore osteophytes)
- functionally normal MCL: correctable deformity (normal medial opening)
- acceptable patellofemoral joint: normal, medial facet OA with or without bone loss, lateral facet OA without bone loss.
- 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
- 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.
Key Trial Info
Start Date :
April 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT04518111
Start Date
April 24 2021
End Date
December 31 2024
Last Update
May 23 2024
Active Locations (1)
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1
Beijing Chaoyang Emergency Medical Center
Beijing, China, 110105