Trials / Enrolling By Invitation
Enrolling By InvitationNCT04518111
Oxford UKA and HTO Post-market Clinical Study
Early Clinical Outcome of Medial Unicompartmental Knee Arthroplasty (UKA) and High Tibial Osteotomy (HTO) for the Treatment of Anteromedial Osteoarthritis (AMOA) in Chinese Population
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 370 (estimated)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
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 assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome, then identify factors associated with better clinical performance. It is aimed to provide evidence-based guidelines for selecting the appropriate procedure in managing AMOA in Chinese population based on the findings of this study. The secondary endpoints will include: 1. Pain Numerical Rating Scale (NRS) 2. SF-12 Health Survey 3. Radiographic assessment includes pre-op and post-op mechanical femorotibial angle (mFTA), patella height, patellofemoral medial and lateral articular surfaces, and displacement angle of patella 4. Range of motion 5. Adverse event rate and classification (including complication) 6. Operating time 7. Total blood loss (BRECHER formula) 8. Revision rate Health economic outcomes based on hospital discharge days, recovery time, physiotherapy and complications/ reoperations will also be analyzed.
Conditions
Timeline
- Start date
- 2021-04-24
- Primary completion
- 2024-09-30
- Completion
- 2024-12-31
- First posted
- 2020-08-19
- Last updated
- 2024-05-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04518111. Inclusion in this directory is not an endorsement.