Osteonecrosis
Conditions
Keywords
osteonecrosis, osteonecrotic repair device
Brief 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.
Interventions
PROCEDURECore Decompression
10 patients will be randomized chosen in this group
PROCEDUREOsteonecrotic Repair Device
10 patients will be randomized chosen in this group
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Each patients will be divided into treatment group (osteonecrotic repair device) or control group (core decompression)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC) | Baseline before procedure/surgery up to follow up 2 years after | Questionaire Scoring |
| Visual Analogue Scale(VAS) | Baseline before procedure/surgery up to follow up 2 years after | Subjective Pain Scoring |
| Harris Hip Score (HHS) | Baseline before procedure/surgery up to follow up 2 years after | Scoring |
Outcome results
None listed