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A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

NCT04103944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-09-26

No results posted yet for this study

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.

Conditions

  • Osteonecrosis

Interventions

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

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-01
Primary Completion
2017-05-31
Completion
2017-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103944 on ClinicalTrials.gov