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Proximal Femur Locking Compression Plates Versus Trochanteric Nails

Primary Purpose

Reverse Oblique Intertrochanteric Fractures, Reverse Oblique Subtrochanteric Fractures

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Proximal femur locking plate
Intertrochanteric nail
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reverse Oblique Intertrochanteric Fractures focused on measuring Reverse oblique intertrochanteric fractures, Reverse oblique subtrochanteric fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Alexandra Hospital
  • Cantonal Hospital Chur
  • Cantonal Hospital Lucerne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Proximal femur locking plate

Trochanteric nail

Arm Description

Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc)

Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN)

Outcomes

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.
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
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
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
Satisfaction measured with the VAS
Abductor muscle function with the Trendelenburg sign analysis
Abductor muscle function test
Surgical details
Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.
Local complications
Local complication will be recorded and categorized: Implant / surgery complications, Bone / fracture complications, Soft tissue / wound complications.
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.
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.
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.
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.

Full Information

First Posted
May 20, 2010
Last Updated
August 11, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
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1. Study Identification

Unique Protocol Identification Number
NCT01128868
Brief Title
Proximal Femur Locking Compression Plates Versus Trochanteric Nails
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 Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reverse Oblique Intertrochanteric Fractures, Reverse Oblique Subtrochanteric Fractures
Keywords
Reverse oblique intertrochanteric fractures, Reverse oblique subtrochanteric fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proximal femur locking plate
Arm Type
Active Comparator
Arm Description
Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc)
Arm Title
Trochanteric nail
Arm Type
Other
Arm Description
Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN)
Intervention Type
Device
Intervention Name(s)
Proximal femur locking plate
Other Intervention Name(s)
LCP Proximal Femur Plate (Synthes), LCP Proximal Femur Hook Plate (Synthes), PeriLoc Periarticular Locked Plating System (Smith & Nephew)
Intervention Description
Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)
Intervention Type
Device
Intervention Name(s)
Intertrochanteric nail
Other Intervention Name(s)
Proximal Femoral Nail Antirotation (Synthes), Titanium Trochanteric Fixation Nail (Synthes), Gamma Trochanteric Nail (Stryker)
Intervention Description
Intertrochanteric nail (PFNA, TFN, GN)
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
one year
Secondary Outcome Measure Information:
Title
Patient outcome
Description
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.
Time Frame
one year
Title
Pain scores on the Visual Analog Scale
Description
Pain will be measured with the Visual Analogue Scale (VAS) (additionally assessed in a subgroup with the Brief Pain Inventory [BPI]).
Time Frame
one year
Title
Patient satisfaction with the Visual Analogue Scale
Description
Satisfaction measured with the VAS
Time Frame
one year
Title
Abductor muscle function with the Trendelenburg sign analysis
Description
Abductor muscle function test
Time Frame
one year
Title
Surgical details
Description
Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.
Time Frame
Initial hospitalization
Title
Local complications
Description
Local complication will be recorded and categorized: Implant / surgery complications, Bone / fracture complications, Soft tissue / wound complications.
Time Frame
one year
Title
Revision rate
Description
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.
Time Frame
one year
Title
Systemic or general complications
Description
All complications affecting other regions of the body will be documented and evaluated as general/systemic complications, eg, thromboembolic complications, sepsis and others.
Time Frame
one year
Title
Exploration of prognostic factors for the occurrence of complications, using the Fracture Risk Assessment Tool (FRAX)
Description
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.
Time Frame
Initial hospitalization
Title
Quality of reduction
Description
The results of fracture reduction are assessed with the following clinical and radiological evaluations : Varus/valgus deformity, Endo-/exorotation deformity, Limb length.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beate P. Hanson, MD
Organizational Affiliation
AO Clinical Investigation and Documentation, Davos, Switzerland
Official's Role
Study Director
Facility Information:
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Cantonal Hospital Chur
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Cantonal Hospital Lucerne
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland

12. IPD Sharing Statement

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Proximal Femur Locking Compression Plates Versus Trochanteric Nails

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