Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteonecrotic Repair Device | Experimental | 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. |
|
| Core Decompression | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Decompression | Procedure | 10 patients will be randomized chosen in this group |
| |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
Each patients will be divided into treatment group (osteonecrotic repair device) or control group (core decompression)
Not provided
Not provided
Not provided
| Osteonecrotic Repair Device |
| Procedure |
10 patients will be randomized chosen in this group |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |