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

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ClinicalTrials.gov Identifier: NCT00756431
Recruitment Status : Withdrawn (No data so far)
First Posted : September 22, 2008
Last Update Posted : June 19, 2017
Sponsor:
Collaborators:
Hvidovre University Hospital
Biomet U.K. Ltd.
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Hip Fracture reduction Screw without HA Coating (Hiploc) Device: Hip Fracture reduction Screw with HA Coating (Hiploc) Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : January 2004
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 3months, 6 months ]

Secondary Outcome Measures :
  1. DEXA [ Time Frame: 3months, 6 months ]
  2. RSA [ Time Frame: 3months,6 months ]
  3. Complications [ Time Frame: Anytime ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with trochanteric femoral fractures

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756431


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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00756431     History of Changes
Other Study ID Numbers: BMET UK 06
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017

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