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

Not Applicable

Withdrawn

• Conditions: Osteoarthritis
• Interventions: Device: Hip Fracture reduction Screw without HA Coating (Hiploc); Device: Hip Fracture reduction Screw with HA Coating (Hiploc)

• Registration Number: NCT00756431
• Lead Sponsor: Zimmer Biomet

Brief Summary

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

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 Timeline

• Study Start: 2004-01
• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-19
• Study First Posted: 2008-09-22
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with trochanteric femoral fractures

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Screw without HA Coating (Hiploc)	Hip Fracture reduction Screw without HA Coating (Hiploc)	-
Screw with HA Coating (Hiploc)	Hip Fracture reduction Screw with HA Coating (Hiploc)	-

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	3months, 6 months

Secondary Outcome Measures

Name	Time	Method
DEXA	3months, 6 months
Complications	Anytime
RSA	3months,6 months