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Proximal Femur Locking Compression Plates Versus Trochanteric Nails

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01128868
First received: May 20, 2010
Last updated: July 30, 2014
Last verified: July 2014

May 20, 2010
July 30, 2014
May 2011
June 2013   (final data collection date for primary outcome 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. [ Time Frame: one year ] [ Designated as safety issue: No ]
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).
Compare the fuctional 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 ] [ Designated as safety issue: No ]
As hip abductors are the most important muscles around the hip joint, the primary outcome parameter will involve objectively measuring hip abductor strength. Muscle strengt will be assessed with a portable handheld dynamometer (Model 01163, Lafayette Instrument Company, Lafayette, IN, USA).
Complete list of historical versions of study NCT01128868 on ClinicalTrials.gov Archive Site
  • Patient outcome [ Time Frame: one year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Abductor muscle function with the Trendelenburg sign analysis [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Surgical details [ Time Frame: Initial hospitalization ] [ Designated as safety issue: No ]
    Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.
  • Local complications [ Time Frame: one year ] [ Designated as safety issue: No ]

    Local complication will be recorded and categorized:

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

  • Revision rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    The results of fracture reduction are assessed with the following clinical and radiological evaluations : Varus/valgus deformity, Endo-/exorotation deformity, Limb length.
  • Patient outcome [ Time Frame: one year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Abductor muscle function with the Trendelenburg sign analysis [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Surgical details [ Time Frame: Initial hospitalization ] [ Designated as safety issue: No ]
    Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience
  • Local complications [ Time Frame: one year ] [ Designated as safety issue: No ]

    Local complication will be recorded and categorized:

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

  • Revision rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    The results of fracture reduction are assessed with the following clinical and radiological evaluations : Varus/valgus deformity, Endo-/exorotation deformity, Limb length
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Reverse Oblique Intertrochanteric Fractures
  • Reverse Oblique Subtrochanteric Fractures
  • 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)
  • Device: Intertrochanteric nail
    Intertrochanteric nail (PFNA, TFN, GN)
    Other Names:
    • Proximal Femoral Nail Antirotation (Synthes)
    • Titanium Trochanteric Fixation Nail (Synthes)
    • Gamma Trochanteric Nail (Stryker)
  • 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)
    Intervention: Device: Proximal femur locking plate
  • Trochanteric nail
    Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN)
    Intervention: Device: Intertrochanteric nail
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
July 2014
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Switzerland
 
NCT01128868
PF LCPs vs Trochanteric Nail
Yes
AO Clinical Investigation and Documentation
AO Clinical Investigation and Documentation
Not Provided
Study Director: Beate P. Hanson, MD AO Clinical Investigation and Documentation, Davos, Switzerland
AO Clinical Investigation and Documentation
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP