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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00756431
First Posted: September 22, 2008
Last Update Posted: June 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hvidovre University Hospital
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Zimmer Biomet
September 19, 2008
September 22, 2008
June 19, 2017
January 2004
June 2010   (Final data collection date for primary outcome measure)
Harris Hip Score [ Time Frame: 3months, 6 months ]
Same as current
Complete list of historical versions of study NCT00756431 on ClinicalTrials.gov Archive Site
  • DEXA [ Time Frame: 3months, 6 months ]
  • RSA [ Time Frame: 3months,6 months ]
  • Complications [ Time Frame: Anytime ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Denmark
 
NCT00756431
BMET UK 06
No
Not Provided
Not Provided
Zimmer Biomet
Zimmer Biomet
  • Hvidovre University Hospital
  • Biomet U.K. Ltd.
Principal Investigator: Hendrik Palm, MD Hvidovre Univ. Hospital
Zimmer Biomet
June 2017

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