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

Sponsor
Zimmer Biomet (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00756431
Collaborator
Hvidovre University Hospital (Other), Biomet U.K. Ltd. (Industry)
0
Enrollment
2
Arms
77
Duration (Months)

Study Details

Study Description

Brief Summary

Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures

Condition or Disease Intervention/Treatment Phase
  • Device: Hip Fracture reduction Screw without HA Coating (Hiploc)
  • Device: Hip Fracture reduction Screw with HA Coating (Hiploc)
 N/A

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

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Screw without HA Coating (Hiploc)

Device: Hip Fracture reduction Screw without HA Coating (Hiploc)
Hip Fracture reduction Screw without HA Coating (Hiploc)
Other Names:
  • Hiploc

    		•
    Experimental: Screw with HA Coating (Hiploc)

    Device: Hip Fracture reduction Screw with HA Coating (Hiploc)
    Hip Fracture reduction Screw with HA Coating (Hiploc)
    Other Names:
  • Hiploc

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Harris Hip Score [3months, 6 months]

    Secondary Outcome Measures

    1. DEXA [3months, 6 months]

    2. RSA [3months,6 months]

    3. Complications [Anytime]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with trochanteric femoral fractures
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zimmer Biomet
    • Hvidovre University Hospital
    • Biomet U.K. Ltd.

    Investigators

    • Principal Investigator: Hendrik Palm, MD, Hvidovre Univ. Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT00756431
    Other Study ID Numbers:
    • BMET UK 06
    First Posted:
    Sep 22, 2008
    Last Update Posted:
    Jun 19, 2017
    Last Verified:
    Jun 1, 2017
    Additional relevant MeSH terms:
    Femoral Fractures

    Study Results

    No Results Posted as of Jun 19, 2017