A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

Osteonecrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04103944
• Other study ID #: 201111037DIB
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteonecrosis

Intervention

Procedure:
• Core Decompression
10 patients will be randomized chosen in this group
• Osteonecrotic Repair Device
10 patients will be randomized chosen in this group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

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