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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01128868
Registration number
NCT01128868
Ethics application status
Date submitted
20/05/2010
Date registered
24/05/2010
Date last updated
13/08/2020
Titles & IDs
Public title
Proximal Femur Locking Compression Plates Versus Trochanteric Nails
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Scientific 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
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Secondary ID [1]
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PF LCPs vs Trochanteric Nail
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Reverse Oblique Intertrochanteric Fractures
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Reverse Oblique Subtrochanteric Fractures
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Proximal femur locking plate
Treatment: Devices - Intertrochanteric nail
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)
Other: Trochanteric nail - Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN)
Treatment: Devices: Proximal femur locking plate
Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)
Treatment: Devices: Intertrochanteric nail
Intertrochanteric nail (PFNA, TFN, GN)
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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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).
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Timepoint [1]
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one year
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Secondary outcome [1]
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Patient outcome
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Assessment method [1]
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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.
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Timepoint [1]
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one year
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Secondary outcome [2]
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Pain scores on the Visual Analog Scale
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Assessment method [2]
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Pain will be measured with the Visual Analogue Scale (VAS) (additionally assessed in a subgroup with the Brief Pain Inventory \[BPI\]).
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Timepoint [2]
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one year
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Secondary outcome [3]
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Patient satisfaction with the Visual Analogue Scale
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Assessment method [3]
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Satisfaction measured with the VAS
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Timepoint [3]
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one year
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Secondary outcome [4]
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Abductor muscle function with the Trendelenburg sign analysis
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Assessment method [4]
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Abductor muscle function test
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Timepoint [4]
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one year
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Secondary outcome [5]
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Surgical details
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Assessment method [5]
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Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.
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Timepoint [5]
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Initial hospitalization
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Secondary outcome [6]
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Local complications
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Assessment method [6]
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Local complication will be recorded and categorized:
Implant / surgery complications, Bone / fracture complications, Soft tissue / wound complications.
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Timepoint [6]
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one year
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Secondary outcome [7]
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Revision rate
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Assessment method [7]
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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.
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Timepoint [7]
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one year
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Secondary outcome [8]
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Systemic or general complications
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Assessment method [8]
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All complications affecting other regions of the body will be documented and evaluated as general/systemic complications, eg, thromboembolic complications, sepsis and others.
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Timepoint [8]
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one year
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Secondary outcome [9]
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Exploration of prognostic factors for the occurrence of complications, using the Fracture Risk Assessment Tool (FRAX)
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Assessment method [9]
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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.
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Timepoint [9]
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Initial hospitalization
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Secondary outcome [10]
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Quality of reduction
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Assessment method [10]
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The results of fracture reduction are assessed with the following clinical and radiological evaluations : Varus/valgus deformity, Endo-/exorotation deformity, Limb length.
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Timepoint [10]
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one year
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2014
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Sample size
Target
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Accrual to date
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Final
14
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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Switzerland
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State/province [1]
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Chur
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Country [2]
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Switzerland
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State/province [2]
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Lucerne
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Funding & Sponsors
Primary sponsor type
Other
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Name
AO Clinical Investigation and Publishing Documentation
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT01128868
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Beate P. Hanson, MD
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Address
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AO Clinical Investigation and Documentation, Davos, Switzerland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01128868
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