Status:
COMPLETED
A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Osteonecrosis
Eligibility:
All Genders
20-70 years
Phase:
NA
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 osteonecro...
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 coll...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04103944
Start Date
June 1 2014
End Date
December 1 2017
Last Update
September 26 2019
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