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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This study has been withdrawn prior to enrollment.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:
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
History of Changes
  Purpose

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


Condition Intervention
Osteoarthritis
 Device: Hip Fracture reduction Screw without HA Coating (Hiploc)
Device: Hip Fracture reduction Screw with HA Coating (Hiploc)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Harris Hip Score [ Time Frame: 3months, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: January 2004
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Hiploc

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with trochanteric femoral fractures

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756431

Sponsors and Collaborators
Biomet, Inc.
Hvidovre University Hospital
Biomet U.K. Ltd.
Investigators
Principal Investigator: Hendrik Palm, MD Hvidovre Univ. Hospital
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00756431     History of Changes
Other Study ID Numbers: BMET UK 06
Study First Received: September 19, 2008
Last Updated: December 5, 2011
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Femoral Fractures
Osteoarthritis
Fractures, Bone
Wounds and Injuries
Leg Injuries
 Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013