- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531983
Results of Gamma Nail in Trochentric Fractures of the Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hip fractures are considered one of the major health problems in aging societies . These fractures are correlated with increased disability and mortality and a decreased quality of life . Early mobilization of patients with these fractures is essential to improve fracture healing, minimize immediate postsurgical morbidity, and reduce care costs. One essential prerequisite for early mobilization is mechanically stable fracture fixation . Nowadays, most hip fractures are treated by extramedullary or intramedullary implants, which allow a stable fixation in the majority of cases
A dynamic hip screw (DHS) is the most commonly used implant for intertrochanteric fractures . Load bearing in the proximal femur is predominantly through the intact calcar femoral; the lever arm of the laterally placed plate is increased, thus, there is a risk of implant cutout if the calcar is not intact .
Biomechanically, compared with a laterally fixed side plate, an intramedullary device decreases the bending force of the hip joint on the implant by 25-30%. This has advantages especially in elderly patients, in whom the primary treatment goal is immediate full weight-bearing mobilization.
It has been postulated that cephalomedullary nails have an advantage over DHS fixation because of the load-bearing axis being closer to the hip joint fulcrum, and also less blood loss, minimal tissue dissection, shorter operation time, and faster ambulation after surgery . However, other studies have reported that fixation with DHS is better . One of the major drawbacks discovered with the use of the gamma nail is a higher reoperation rate as a result of new fracture around the implant . In this study, we present our results for the treatment of trochentric fractures using a gamma nail in terms of the outcome, drawbacks, and possible complications.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age (20-70)
- unstable trochentric fractures
Exclusion Criteria:
- pathological fractures due to neoplasia
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with failure of initial intervention
Time Frame: 1 year
|
case series prospective study for 30 patients who were admitted to AUH during 18-month period from December 2018 to May 2019
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G.nail in trochentric frs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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