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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
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
Secondary ID [1] 0 0
PF LCPs vs Trochanteric Nail
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reverse Oblique Intertrochanteric Fractures 0 0
Reverse Oblique Subtrochanteric Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
one year
Secondary outcome [1] 0 0
Patient outcome
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
one year
Secondary outcome [2] 0 0
Pain scores on the Visual Analog Scale
Assessment method [2] 0 0
Pain will be measured with the Visual Analogue Scale (VAS) (additionally assessed in a subgroup with the Brief Pain Inventory \[BPI\]).
Timepoint [2] 0 0
one year
Secondary outcome [3] 0 0
Patient satisfaction with the Visual Analogue Scale
Assessment method [3] 0 0
Satisfaction measured with the VAS
Timepoint [3] 0 0
one year
Secondary outcome [4] 0 0
Abductor muscle function with the Trendelenburg sign analysis
Assessment method [4] 0 0
Abductor muscle function test
Timepoint [4] 0 0
one year
Secondary outcome [5] 0 0
Surgical details
Assessment method [5] 0 0
Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.
Timepoint [5] 0 0
Initial hospitalization
Secondary outcome [6] 0 0
Local complications
Assessment method [6] 0 0
Local complication will be recorded and categorized: Implant / surgery complications, Bone / fracture complications, Soft tissue / wound complications.
Timepoint [6] 0 0
one year
Secondary outcome [7] 0 0
Revision rate
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
one year
Secondary outcome [8] 0 0
Systemic or general complications
Assessment method [8] 0 0
All complications affecting other regions of the body will be documented and evaluated as general/systemic complications, eg, thromboembolic complications, sepsis and others.
Timepoint [8] 0 0
one year
Secondary outcome [9] 0 0
Exploration of prognostic factors for the occurrence of complications, using the Fracture Risk Assessment Tool (FRAX)
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Initial hospitalization
Secondary outcome [10] 0 0
Quality of reduction
Assessment method [10] 0 0
The results of fracture reduction are assessed with the following clinical and radiological evaluations : Varus/valgus deformity, Endo-/exorotation deformity, Limb length.
Timepoint [10] 0 0
one year

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Switzerland
State/province [1] 0 0
Chur
Country [2] 0 0
Switzerland
State/province [2] 0 0
Lucerne

Funding & Sponsors
Primary sponsor type
Other
Name
AO Clinical Investigation and Publishing Documentation
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Beate P. Hanson, MD
Address 0 0
AO Clinical Investigation and Documentation, Davos, Switzerland
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
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