A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

NCT04103944 | Completed FDA Device

• 1 other identifier: 201111037DIB
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteonecrosis

Keywords

osteonecrosis; osteonecrotic repair device

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Osteonecrotic Repair Device

EXPERIMENTAL

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

Core Decompression

ACTIVE COMPARATOR

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

Interventions

Core Decompression PROCEDURE

10 patients will be randomized chosen in this group

Core Decompression

Osteonecrotic Repair Device PROCEDURE

10 patients will be randomized chosen in this group

Osteonecrotic Repair Device

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patients will be divided into treatment group (osteonecrotic repair device) or control group (core decompression)

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: June 1, 2014
• Primary Completion: May 31, 2017
• Study Completion: December 1, 2017
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share