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Oxford UKA and HTO Post-market Clinical Study

Knee Osteoarthritis Clinical Trial

Official title:
Early Clinical Outcome of Medial Unicompartmental Knee Arthroplasty (UKA) and High Tibial Osteotomy (HTO) for the Treatment of Anteromedial Osteoarthritis (AMOA) in Chinese Population

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04518111
Study type Observational
Source Zimmer Biomet
Contact
Status Enrolling by invitation
Phase
Start date April 24, 2021
Completion date December 31, 2024
View Details
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