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A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

Primary Purpose

Osteonecrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Core Decompression
Osteonecrotic Repair Device
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteonecrosis focused on measuring osteonecrosis, osteonecrotic repair device

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Osteonecrotic Repair Device

    Core Decompression

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC)
    Questionaire Scoring
    Visual Analogue Scale(VAS)
    Subjective Pain Scoring
    Harris Hip Score (HHS)
    Scoring

    Secondary Outcome Measures

    Full Information

    First Posted
    September 24, 2019
    Last Updated
    September 24, 2019
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04103944
    Brief Title
    A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2014 (Actual)
    Primary Completion Date
    May 31, 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteonecrosis
    Keywords
    osteonecrosis, osteonecrotic repair device

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Each patients will be divided into treatment group (osteonecrotic repair device) or control group (core decompression)
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Osteonecrotic Repair Device
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Core Decompression
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Core Decompression
    Intervention Description
    10 patients will be randomized chosen in this group
    Intervention Type
    Procedure
    Intervention Name(s)
    Osteonecrotic Repair Device
    Intervention Description
    10 patients will be randomized chosen in this group
    Primary Outcome Measure Information:
    Title
    Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC)
    Description
    Questionaire Scoring
    Time Frame
    Baseline before procedure/surgery up to follow up 2 years after
    Title
    Visual Analogue Scale(VAS)
    Description
    Subjective Pain Scoring
    Time Frame
    Baseline before procedure/surgery up to follow up 2 years after
    Title
    Harris Hip Score (HHS)
    Description
    Scoring
    Time Frame
    Baseline before procedure/surgery up to follow up 2 years after

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation

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