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A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

Osteonecrosis Clinical Trial

Clinical Trial Summary

Numerous studies describing surgical treatments to preserve hip replacements has several controversies and none of these procedures are universally accepted nor have compelling evidence for osteonecrosis of the femoral head (ONFH). With developing a newly approach osteonecrotic device surgical procedure to support the regeneration of necrotic bone and articular cartilage in vivo, this will be the first randomized-controlled feasibility study to determine its safety in ONFH patients.

Clinical Trial Description

Total of 20 patients were enrolled and randomized in this study. There are two groups, 10 patients in osteonecrotic device group; 10 incore decompression group. After their baseline data has been collected and their surgical procedure has been completed, the following postoperative data collection are then continued to 6 weeks, 12 weeks, 6 months, one year, and two years' prior from the start of their surgery, in order to understand the new approach of the osteonecrotic device's safety in comparison to the core decompression surgical procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04103944
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Completed
Phase N/A
Start date June 1, 2014
Completion date December 2017
View Details
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