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Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Primary Purpose

Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hip Fracture reduction Screw without HA Coating (Hiploc)
Hip Fracture reduction Screw with HA Coating (Hiploc)
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with trochanteric femoral fractures

Exclusion Criteria:

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Screw without HA Coating (Hiploc)

    Screw with HA Coating (Hiploc)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Harris Hip Score

    Secondary Outcome Measures

    DEXA
    RSA
    Complications

    Full Information

    First Posted
    September 19, 2008
    Last Updated
    June 16, 2017
    Sponsor
    Zimmer Biomet
    Collaborators
    Hvidovre University Hospital, Biomet U.K. Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00756431
    Brief Title
    Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
    Official Title
    Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No data so far
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    June 2010 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zimmer Biomet
    Collaborators
    Hvidovre University Hospital, Biomet U.K. Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures
    Detailed Description
    Randomised study to determine the effect of HA coating on the stability of lag screws used to reduce femoral neck fractures. Stability of the screw will be determined by RSA measurements. The effect of the HA coating on bone remodeling will be determined by DEXA measurements

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Screw without HA Coating (Hiploc)
    Arm Type
    Active Comparator
    Arm Title
    Screw with HA Coating (Hiploc)
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Hip Fracture reduction Screw without HA Coating (Hiploc)
    Other Intervention Name(s)
    Hiploc
    Intervention Description
    Hip Fracture reduction Screw without HA Coating (Hiploc)
    Intervention Type
    Device
    Intervention Name(s)
    Hip Fracture reduction Screw with HA Coating (Hiploc)
    Other Intervention Name(s)
    Hiploc
    Intervention Description
    Hip Fracture reduction Screw with HA Coating (Hiploc)
    Primary Outcome Measure Information:
    Title
    Harris Hip Score
    Time Frame
    3months, 6 months
    Secondary Outcome Measure Information:
    Title
    DEXA
    Time Frame
    3months, 6 months
    Title
    RSA
    Time Frame
    3months,6 months
    Title
    Complications
    Time Frame
    Anytime

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with trochanteric femoral fractures Exclusion Criteria:
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hendrik Palm, MD
    Organizational Affiliation
    Hvidovre Univ. Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

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