NCT04103944

A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteonecrosis

Interventions

Type	Name	Description
PROCEDURE	Core Decompression	10 patients will be randomized chosen in this group
PROCEDURE	Osteonecrotic Repair Device	10 patients will be randomized chosen in this group

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-05-31
• Completion: 2017-12-01
• First posted: 2019-09-26
• Last updated: 2019-09-26

Regulatory

• FDA-regulated device study