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Completed

NCT Number: NCT01128868

Proximal Femur Locking Compression Plates Versus Trochanteric Nails

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).

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Key information

Conditions

Reverse Oblique Intertrochanteric Fractures Reverse Oblique Subtrochanteric Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proximal femur locking plate

Device

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)

Intertrochanteric nail

Device

Intertrochanteric nail (PFNA, TFN, GN)

Other names: Proximal Femoral Nail Antirotation (Synthes), Titanium Trochanteric Fixation Nail (Synthes), Gamma Trochanteric Nail (Stryker)

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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]).

  3. Patient satisfaction with the Visual Analogue Scale

    Time frame: one year

    Satisfaction measured with the VAS

  4. Abductor muscle function with the Trendelenburg sign analysis

    Time frame: one year

    Abductor muscle function test

  5. Surgical details

    Time frame: Initial hospitalization

    Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.

  6. Local complications

    Time frame: one year

    Local complication will be recorded and categorized:

    Implant / surgery complications, Bone / fracture complications, Soft tissue / wound complications.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
May 24, 2010
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.