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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03975868
Other study ID # 30342858
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2009
Est. completion date March 31, 2015

Study information

Verified date June 2019
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 228
Est. completion date March 31, 2015
Est. primary completion date March 31, 2015
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type Measure Description Time frame Safety issue
Primary Mechanical failure defined by varus fracture collapse and lag-screw cut-out with extrusion through the femoral head 3 months
See also
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Completed NCT01673776 - Multimodal Approach to Improve the Outcome of Patients With a Proximal Femoral Fracture N/A
Completed NCT03768622 - Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome