A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

Study Overview
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Brief Summary
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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
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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
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Osteonecrosis

Intervention / Treatment
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* Procedure: Core Decompression
* Procedure: Osteonecrotic Repair Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally matured between age 20 to 70 (epiphyses of the femoral head are confirmed to be closed on the radiography, CT, or MRI scan Patients without any allergies or major systemic or organ diseases Patient's affected hip diagnossied as the 3rd stage of ONFH by MRI Exclusion Criteria: Other lower lib fractures Pregnancy Extensive degenerative arthritis in hip Severe osteoporosis in the head and/or neck of the femoral bone Rheumatoid immunity or metabolic arthritis that appears to have severe cartilage damage in the hip Stiffness in the hip due to other reasons or medical history with its range of motion clinically measures less than 20 degrees in the abduction and less than 90 degrees flexion Diagnosed with either Stage 4, 5, or 6, of ONFH classification by either radiography, MR, CT scan.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patients will be divided into treatment group (osteonecrotic repair device) or control group (core decompression)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteonecrotic Repair Device<br>A biphasic osteochrondral composite method to support the regeneration of articular cartilage in vivo. With its concept that could be securely installed by press-fit without additional fixation, this approach can present an alternative to perform graft harvest and implantation in a single surgery. | Procedure: Osteonecrotic Repair Device<br>* 10 patients will be randomized chosen in this group<br>|
| Active Comparator: Core Decompression<br>Core decompression is a common surgical procedure that aims to improve vascular inflow by decreasing intraosseous pressure in the femoral head. It is performed that involves removing a cylindrical core of bone from the proximal femur. | Procedure: Core Decompression<br>* 10 patients will be randomized chosen in this group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC) | Questionaire Scoring | Baseline before procedure/surgery up to follow up 2 years after | 
| Visual Analogue Scale(VAS) | Subjective Pain Scoring | Baseline before procedure/surgery up to follow up 2 years after | 
| Harris Hip Score (HHS) | Scoring | Baseline before procedure/surgery up to follow up 2 years after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteonecrosis, osteonecrotic repair device