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NCT00756431 Clinical Trial

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

Osteoarthritis Clinical Trial

Official title:
Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00756431
Other study ID # BMET UK 06
Secondary ID
Status Withdrawn
Phase N/A
First received September 19, 2008
Last updated June 16, 2017
Start date January 2004
Est. completion date June 2010

Study information
Verified date June 2017
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with trochanteric femoral fractures

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Hip Fracture reduction Screw without HA Coating (Hiploc)
Hip Fracture reduction Screw without HA Coating (Hiploc)
• Hip Fracture reduction Screw with HA Coating (Hiploc)
Hip Fracture reduction Screw with HA Coating (Hiploc)

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Zimmer Biomet Biomet U.K. Ltd., Hvidovre University Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Harris Hip Score 3months, 6 months
Secondary DEXA 3months, 6 months
Secondary RSA 3months,6 months
Secondary Complications Anytime
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