Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
June 16, 2017 updated by: Zimmer Biomet
Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures
Study Overview
Status
Withdrawn
Conditions
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
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with trochanteric femoral fractures
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Screw without HA Coating (Hiploc)
|
Hip Fracture reduction Screw without HA Coating (Hiploc)
Other Names:
|
|
Experimental: Screw with HA Coating (Hiploc)
|
Hip Fracture reduction Screw with HA Coating (Hiploc)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Harris Hip Score
Time Frame: 3months, 6 months
|
3months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complications
Time Frame: Anytime
|
Anytime
|
|
DEXA
Time Frame: 3months, 6 months
|
3months, 6 months
|
|
RSA
Time Frame: 3months,6 months
|
3months,6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hendrik Palm, MD, Hvidovre Univ. Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
September 19, 2008
First Submitted That Met QC Criteria
September 19, 2008
First Posted (Estimate)
September 22, 2008
Study Record Updates
Last Update Posted (Actual)
June 19, 2017
Last Update Submitted That Met QC Criteria
June 16, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMET UK 06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.