A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation
Osteonecrosis
About this trial
This is an interventional treatment trial for Osteonecrosis focused on measuring osteonecrosis, osteonecrotic repair device
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Osteonecrotic Repair Device
Core Decompression
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 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.