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 10, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Reverse Oblique Intertrochanteric Fractures
Reverse Oblique Subtrochanteric Fractures
Device: Proximal femur locking plate
Device: Intertrochanteric nail
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: May 2011
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128868

Locations
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Switzerland
Cantonal Hospital Chur
Chur, Switzerland, 7000
Cantonal Hospital Lucerne
Lucerne, Switzerland, 6000
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Study Director: Beate P. Hanson, MD AO Clinical Investigation and Documentation, Davos, Switzerland
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01128868     History of Changes
Other Study ID Numbers: PF LCPs vs Trochanteric Nail
Study First Received: May 20, 2010
Last Updated: July 10, 2013
Health Authority: Australia: Human Research Ethics Committee
Brazil: Ethics Committee
Canada: Ethics Review Committee
Switzerland: Ethikkommission
United States: Institutional Review Board

Keywords provided by AO Clinical Investigation and Documentation:
Reverse oblique intertrochanteric fractures
Reverse oblique subtrochanteric fractures

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 20, 2014