Proximal Femur Locking Compression Plates Versus Trochanteric Nails
NCT ID: NCT01128868
Last Updated: 2020-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2011-05-31
2014-07-31
Brief Summary
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"Proximal femur locking plates" stands for both the PF-LCP (Synthes) and the PeriLoc (Smith \& Nephew). Trochanteric nails allowed in this study are the Proximal Femoral Nail Antirotation (PFNA), the Titanium Trochanteric Fixation Nail (TFN) and the Gamma Nail (GN).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Proximal femur locking plate
Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc)
Proximal femur locking plate
Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)
Trochanteric nail
Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN)
Intertrochanteric nail
Intertrochanteric nail (PFNA, TFN, GN)
Interventions
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Proximal femur locking plate
Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)
Intertrochanteric nail
Intertrochanteric nail (PFNA, TFN, GN)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with closed or type 1 open reverse oblique intertrochanteric fractures (AO 31 - A3) or subtrochanteric fractures (transverse fracture line, main fracture line maximum 5 cm distal from the lesser trochanter; proximal extension of fracture allowed)
* Definitive fracture fixation with either a proximal femur locking plate or an intertrochanteric nail within 4 days after accident
* Signed written informed consent (by the subject or legal guardian) and agreement to attend the planned FUs
* Able to understand and read country national language at an elementary level
Exclusion Criteria
* Polytrauma
* Any displacement of a femoral neck fracture
* Additional fracture of one of the lower extremities that significantly affects the functional outcome
* Additional injury of the lower limb that significantly affects the functional outcome
* Fractures of the upper extremity if it affects the mobility of the patient
* Type 2 or 3 open fracture
* Drug or alcohol abuse
* Active malignancy
* ASA class V and VI
* Inability to walk independently prior to injury
* Neurological and psychiatric disorders that would preclude reliable assessment
* Patient is not able to come to the regular FUs
* Patients who have participated in any other device or drug related clinical trial within the previous month
* Pregnancy (tested with a urine pregnancy test) or women planning to conceive within the study period
18 Years
ALL
No
Sponsors
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AO Clinical Investigation and Publishing Documentation
OTHER
Responsible Party
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Principal Investigators
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Beate P. Hanson, MD
Role: STUDY_DIRECTOR
AO Clinical Investigation and Documentation, Davos, Switzerland
Locations
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Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Cantonal Hospital Chur
Chur, , Switzerland
Cantonal Hospital Lucerne
Lucerne, , Switzerland
Countries
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Other Identifiers
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PF LCPs vs Trochanteric Nail
Identifier Type: -
Identifier Source: org_study_id
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