Early Clinical Outcome of Medial Unicompartmental Knee Arthroplasty (UKA) and High Tibial Osteotomy (HTO) for the Treatment of Anteromedial Osteoarthritis (AMOA) in Chinese Population
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- STATUS
- Recruiting
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- days left to enroll
- 82
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- participants needed
- 370
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- sponsor
- Zimmer Biomet
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.
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:
- Pain Numerical Rating Scale (NRS)
- SF-12 Health Survey
- 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
- Range of motion
- Adverse event rate and classification (including complication)
- Operating time
- Total blood loss (BRECHER formula)
- Revision rate
Health economic outcomes based on hospital discharge days, recovery time, physiotherapy and complications/ reoperations will also be analyzed.
Details
| Condition | Knee Osteoarthritis |
|---|---|
| Clinical Study Identifier | NCT04518111 |
| Sponsor | Zimmer Biomet |
| Last Modified on | 23 October 2022 |
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