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

This study has been withdrawn prior to enrollment.
(No data so far)
Sponsor:
Collaborators:
Hvidovre University Hospital
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00756431
First received: September 19, 2008
Last updated: December 5, 2011
Last verified: November 2011

September 19, 2008
December 5, 2011
January 2004
June 2010   (final data collection date for primary outcome measure)
Harris Hip Score [ Time Frame: 3months, 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00756431 on ClinicalTrials.gov Archive Site
  • DEXA [ Time Frame: 3months, 6 months ] [ Designated as safety issue: No ]
  • RSA [ Time Frame: 3months,6 months ] [ Designated as safety issue: No ]
  • Complications [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Device: Hip Fracture reduction Screw without HA Coating (Hiploc)
    Hip Fracture reduction Screw without HA Coating (Hiploc)
    Other Name: Hiploc
  • Device: Hip Fracture reduction Screw with HA Coating (Hiploc)
    Hip Fracture reduction Screw with HA Coating (Hiploc)
    Other Name: Hiploc
  • Active Comparator: Screw without HA Coating (Hiploc)
    Intervention: Device: Hip Fracture reduction Screw without HA Coating (Hiploc)
  • Experimental: Screw with HA Coating (Hiploc)
    Intervention: Device: Hip Fracture reduction Screw with HA Coating (Hiploc)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with trochanteric femoral fractures

Exclusion Criteria:

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00756431
BMET UK 06
No
Biomet, Inc.
Biomet, Inc.
  • Hvidovre University Hospital
  • Biomet U.K. Ltd.
Principal Investigator: Hendrik Palm, MD Hvidovre Univ. Hospital
Biomet, Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP