Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures - Full Text View

Sponsors and Collaborators:	Biomet, Inc. Hvidovre University Hospital
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00756431

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)

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

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 ]

Estimated Enrollment:	40
Study Start Date:	January 2004
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Device: Hip Fracture reduction Screw without HA Coating (Hiploc) Hip Fracture reduction Screw without HA Coating (Hiploc)
2: Experimental	Device: Hip Fracture reduction Screw with HA Coating (Hiploc) Hip Fracture reduction Screw with HA Coating (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

Locations

Denmark
Hvidovre Univ. Hospital
HVIDOVRE, Denmark

Sponsors and Collaborators

Biomet, Inc.

Hvidovre University Hospital

Investigators

Principal Investigator:

Hendrik Palm, MD

Hvidovre Univ. Hospital

More Information

No publications provided

Responsible Party:	Biomet UK ( David Stephenson )
Study ID Numbers:	BMET UK 06
Study First Received:	September 19, 2008
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00756431 History of Changes
Health Authority:	Denmark: Ethics Committee

Study placed in the following topic categories:

Femoral Fractures
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Rheumatic Diseases

Additional relevant MeSH terms:

Femoral Fractures
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009