Proximal Femoral Fracture Clinical Trial
Official title:
Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.
| 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 |
| Verified date | June 2019 |
| Source | Fondation Ophtalmologique Adolphe de Rothschild |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Fondation Ophtalmologique Adolphe de Rothschild |
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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