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Results of Gamma Nail in Trochentric Fractures of the Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531983
Recruitment Status : Unknown
Verified January 2019 by Ahmed Gamal Helmy, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 22, 2018
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Gamal Helmy, Assiut University

Study Description
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Brief Summary:
We prospectively reviewed the results of 30 patients who had undergone intramedullary fixation with a gamma nail for femur trochentric fractures in AUH. within 1 year

Condition or disease Intervention/treatment
Trochanteric Fractures Procedure: fixation of tochentric fractures by gamma nail

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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Results of Gamma Nail in Trochentric Fractures of the Adults
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Groups and Cohorts
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Intervention Details:
  • Procedure: fixation of tochentric fractures by gamma nail
    • Thirty patients with recent traumatic extracapsular proximal femoral fractures were treated using a short gamma nail of third-generation assembly

Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients who were admitted to AUH with trochentic fracture and treated by gamma nail
Criteria

Inclusion Criteria:

  • Age (20-70)
  • unstable trochentric fractures

Exclusion Criteria:

  • pathological fractures due to neoplasia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531983


Contacts
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Contact: ahmed G helmy 01111858288 ahmedhelmo2@gmail.com

Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Ahmed Gamal Helmy, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03531983    
Other Study ID Numbers: G.nail in trochentric frs
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Gamal Helmy, Assiut University:
gamma nail
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries