Proximal Femur Locking Compression Plates Versus Trochanteric Nails

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

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).

Study Overview

• Status: Completed
• Conditions: Reverse Oblique Intertrochanteric Fractures; Reverse Oblique Subtrochanteric Fractures
• Intervention / Treatment: Device: Proximal femur locking plate; Device: Intertrochanteric nail

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
• Switzerland
  • Chur, Switzerland, 7000
    • Cantonal Hospital Chur
  • Lucerne, Switzerland, 6000
    • Cantonal Hospital Lucerne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Other Names: LCP Proximal Femur Plate (Synthes); LCP Proximal Femur Hook Plate (Synthes); PeriLoc Periarticular Locked Plating System (Smith & Nephew)
OTHER: Trochanteric nail; Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN)	Device: Intertrochanteric nail; Intertrochanteric nail (PFNA, TFN, GN); Other Names: Proximal Femoral Nail Antirotation (Synthes); Titanium Trochanteric Fixation Nail (Synthes); Gamma Trochanteric Nail (Stryker)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient outcome	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.	one year
Pain scores on the Visual Analog Scale	Pain will be measured with the Visual Analogue Scale (VAS) (additionally assessed in a subgroup with the Brief Pain Inventory [BPI]).	one year
Patient satisfaction with the Visual Analogue Scale	Satisfaction measured with the VAS	one year
Abductor muscle function with the Trendelenburg sign analysis	Abductor muscle function test	one year
Surgical details	Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.	Initial hospitalization
Local complications	Local complication will be recorded and categorized: Implant / surgery complications, Bone / fracture complications, Soft tissue / wound complications.	one year
Revision rate	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.	one year
Systemic or general complications	All complications affecting other regions of the body will be documented and evaluated as general/systemic complications, eg, thromboembolic complications, sepsis and others.	one year
Exploration of prognostic factors for the occurrence of complications, using the Fracture Risk Assessment Tool (FRAX)	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.	Initial hospitalization
Quality of reduction	The results of fracture reduction are assessed with the following clinical and radiological evaluations : Varus/valgus deformity, Endo-/exorotation deformity, Limb length.	one year

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 21, 2010
• First Posted (ESTIMATE): May 24, 2010

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Reverse oblique intertrochanteric fractures; Reverse oblique subtrochanteric fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: PF LCPs vs Trochanteric Nail