A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

NCT ID: NCT04103944

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2017-12-31

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.

Conditions

Osteonecrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Osteonecrotic Repair Device

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.

Group Type: EXPERIMENTAL

Osteonecrotic Repair Device

Intervention Type: PROCEDURE

10 patients will be randomized chosen in this group

Core Decompression

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.

Group Type: ACTIVE_COMPARATOR

Core Decompression

Intervention Type: PROCEDURE

10 patients will be randomized chosen in this group

Interventions

Core Decompression

10 patients will be randomized chosen in this group

Intervention Type: PROCEDURE

Osteonecrotic Repair Device

10 patients will be randomized chosen in this group

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

201111037DIB

Identifier Type: -

Identifier Source: org_study_id