- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02391129
Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement
March 17, 2015 updated by: Julian Joestl, Medical University of Vienna
The purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C periprosthetic fracture after primary total hip replacement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
102
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We retrospectively reviewed a consecutive series of 102 patients with Vancouver type-B2, B3 and C periprosthetic fractures and unstable femoral stem, which had been prospectively entered, in our hip-trauma database.
Description
Inclusion Criteria:
- Patients with Vancouver type- BlI, BIII and C fractures and unstable femoral prosthesis stem.
Exclusion Criteria:
- Patients with pathological fractures,
- Vancouver type-A, Bl, and
- stable femoral prosthesis stem,
- Patients with hemi - prosthesis and periprosthetic femoral fractures were excluded from final analysis.
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hyperion Prosthesis
Patients treated with the second generation long-stem revision prosthesis
|
|
Helios Prosthesis
Patients treated with the first generation long-stem revision prosthesis
|
|
Locking compression plate
Patients treated with LCP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Outcome (Range of Motion of the hip)
Time Frame: follow up of at least 1 year
|
Range of Motion of the hip
|
follow up of at least 1 year
|
Radiographic Outcome (boney consolidation of the fracture)
Time Frame: follow up of at least 1 year
|
boney consolidation of the fracture after 3 month, 6 month and at least 1 year after the operation
|
follow up of at least 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient's Mobility (assessed by the Parker's Mobility Score)
Time Frame: follow up of at least 1 year
|
Patient's Mobility assessed by the Parker's Mobility Score
|
follow up of at least 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
March 7, 2015
First Submitted That Met QC Criteria
March 17, 2015
First Posted (Estimate)
March 18, 2015
Study Record Updates
Last Update Posted (Estimate)
March 18, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1674/2014
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.
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