A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Osteonecrosis
• Intervention / Treatment: Procedure: Osteonecrotic Repair Device; Procedure: Core Decompression

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: Osteonecrotic Repair Device; 10 patients will be randomized chosen in this group
ACTIVE_COMPARATOR: 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.	Procedure: Core Decompression; 10 patients will be randomized chosen in this group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): May 31, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (ACTUAL): September 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: osteonecrosis; osteonecrotic repair device
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Musculoskeletal Diseases; Bone Diseases; Osteonecrosis
• Other Study ID Numbers: 201111037DIB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes