Clinical trial NCT01128868: Proximal Femur Locking Compression Plates Versus Trochanteric Nails
Official title: Treatment of Reverse Oblique Intertrochanteric or Subtrochanteric Fractures With a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc) or Trochanteric Nails. A Multicenter Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reverse Oblique Intertrochanteric Fractures
Reverse Oblique Subtrochanteric Fractures
Keywords: Reverse oblique intertrochanteric fractures
Reverse oblique subtrochanteric fractures
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the abductor muscle strength measured with a dynamometer in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail.

"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).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* 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:

* Pathologic fracture
* 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

Primary outcomes:
measure: Compare the functional outcome and abductor muscle strength measured with Lafayette Manual Muscle Tester in patients with reverse oblique inter- or subtrochanteric fractures treated either with a proximal femur locking plate or a trochanteric nail.
timeFrame: one year
Secondary outcomes:
measure: Patient outcome
timeFrame: one year
measure: Pain scores on the Visual Analog Scale
timeFrame: one year
measure: Patient satisfaction with the Visual Analogue Scale
timeFrame: one year
measure: Abductor muscle function with the Trendelenburg sign analysis
timeFrame: one year
measure: Surgical details
timeFrame: Initial hospitalization
measure: Local complications
timeFrame: one year
measure: Revision rate
timeFrame: one year
measure: Systemic or general complications
timeFrame: one year
measure: Exploration of prognostic factors for the occurrence of complications, using the Fracture Risk Assessment Tool (FRAX)
timeFrame: Initial hospitalization
measure: Quality of reduction
timeFrame: one year
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Chur
country: Switzerland
facility: Cantonal Hospital Chur
city: Lucerne
country: Switzerland
facility: Cantonal Hospital Lucerne
Study officials:
affiliation: AO Clinical Investigation and Documentation, Davos, Switzerland
name: Beate P. Hanson, MD
role: STUDY_DIRECTOR
References: