Proximal Femur Locking Compression Plates Versus Trochanteric Nails
|ClinicalTrials.gov Identifier: NCT01128868|
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : January 24, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Reverse Oblique Intertrochanteric Fractures Reverse Oblique Subtrochanteric Fractures||Device: Proximal femur locking plate Device: Intertrochanteric nail||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||July 2014|
Active Comparator: 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)
Device: Proximal femur locking plate
Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)
Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN)
Device: Intertrochanteric nail
Intertrochanteric nail (PFNA, TFN, GN)
- 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. [ Time Frame: one year ]As hip abductors are the most important muscles around the hip joint, the primary outcome parameter will involve objectively measuring hip abductor strength. Muscle strength will be assessed with a portable handheld dynamometer (Model 01163, Lafayette Instrument Company, Lafayette, IN, USA).
- Patient outcome [ Time Frame: one year ]
Patient outcome will be measured using the following outcome measurements:
Mobility measured with the "timed up & go"-test (TUG), Lower Extremity Measure (LEM) for functional outcome, Length of hospital stay, Walking ability (Parker Mobility Score), Capacity to return to pre-residential status, Quality of life (Short Form-36 [SF-36]), Mortality.
- Pain scores on the Visual Analog Scale [ Time Frame: one year ]Pain will be measured with the Visual Analogue Scale (VAS) (additionally assessed in a subgroup with the Brief Pain Inventory [BPI]).
- Patient satisfaction with the Visual Analogue Scale [ Time Frame: one year ]
- Abductor muscle function with the Trendelenburg sign analysis [ Time Frame: one year ]
- Surgical details [ Time Frame: Initial hospitalization ]Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.
- Local complications [ Time Frame: one year ]
Local complication will be recorded and categorized:
Implant / surgery complications, Bone / fracture complications, Soft tissue / wound complications.
- Revision rate [ Time Frame: one year ]Surgical revision includes all secondary surgical interventions that are related to the injury itself or the primary intervention. It is distinguished from planned revisions due to the injury (eg, planned soft tissue procedure) and revisions due to a complication. Revisions due to a complication are undertaken to resolve the problem and will therefore be documented in the complication form.
- Systemic or general complications [ Time Frame: one year ]All complications affecting other regions of the body will be documented and evaluated as general/systemic complications, eg, thromboembolic complications, sepsis and others.
- Exploration of prognostic factors for the occurrence of complications, using the Fracture Risk Assessment Tool (FRAX) [ Time Frame: Initial hospitalization ]
Fracture risk prior to injury will be calculated with the Fracture Risk Assessment Tool [FRAX] (http://www.shef.ac.uk/FRAX/index.htm).
Additionally, the fracture risk will be considered as a prognostic factor (in the absence of regular BMD measurements) for the analysis of complications.
- Quality of reduction [ Time Frame: one year ]The results of fracture reduction are assessed with the following clinical and radiological evaluations : Varus/valgus deformity, Endo-/exorotation deformity, Limb length.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128868
|Princess Alexandra Hospital|
|Woolloongabba, Queensland, Australia, 4102|
|Cantonal Hospital Chur|
|Chur, Switzerland, 7000|
|Cantonal Hospital Lucerne|
|Lucerne, Switzerland, 6000|
|Study Director:||Beate P. Hanson, MD||AO Clinical Investigation and Documentation, Davos, Switzerland|