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Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.

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ClinicalTrials.gov Identifier: NCT03975868
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
Proximal femoral fracture is associated with severe morbidity and mortality and high socioeconomic costs. The main mechanical complication of internal fixation in trochanteric fracture is lag-screw cut-out through the femoral head. Several factors are involved, but remain controversial. The aim of the present study was to determine risk factors for cut-out in internal fixation of extracapsular proximal femoral fracture.

Condition or disease Intervention/treatment
Proximal Femoral Fracture Other: Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.

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Study Type : Observational
Actual Enrollment : 228 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.
Actual Study Start Date : July 2009
Actual Primary Completion Date : March 31, 2015
Actual Study Completion Date : March 31, 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.
    Identification of factors for mechanical failure of internal fixation of extracapsular proximal femoral fracture in over 75 year olds


Primary Outcome Measures :
  1. Mechanical failure defined by varus fracture collapse and lag-screw cut-out with extrusion through the femoral head [ Time Frame: 3 months ]


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients over 75 years old operated on for extracapsular proximal femoral fracture.
Criteria

Inclusion Criteria:

  • Patients over 75 years of age
  • Operated on for extracapsular proximal femoral fracture
  • After bodyheight fall

Exclusion Criteria:

  • Intra-capsular fractures
  • trochantero-diaphyseal fractures
  • subtrochanteric fractures
  • fractures involving pathological bone

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03975868     History of Changes
Other Study ID Numbers: 30342858
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Fondation Ophtalmologique Adolphe de Rothschild:
Cut-out
Gamma nail
Lag-screw
Tip-apex distance
Trochanteric fracture

Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Hip Fractures
Wounds and Injuries
Leg Injuries
Hip Injuries