Reverse Oblique Intertrochanteric FracturesNCT01128868
Proximal Femur Locking Compression Plates Versus Trochanteric Nails
A study testing Proximal femur locking plate and Intertrochanteric nail in people with Reverse Oblique Intertrochanteric Fractures and Reverse Oblique Subtrochanteric Fractures, run by AO Clinical Investigation and Publishing Documentation at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reverse Oblique Intertrochanteric Fractures, Reverse Oblique Subtrochanteric Fractures
- What is being tested?
- Proximal femur locking plate and Intertrochanteric nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
Cantonal Hospital Chur
Chur, 7000
Cantonal Hospital Lucerne
Lucerne, 6000
About this study
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
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).
- Being tested
- Proximal femur locking plate, Intertrochanteric nail
- Keywords
- Reverse oblique intertrochanteric fractures, Reverse oblique subtrochanteric fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal femur locking plateDevice
Also called LCP Proximal Femur Plate (Synthes), LCP Proximal Femur Hook Plate (Synthes), PeriLoc Periarticular Locked Plating System (Smith & Nephew)
Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)
Intertrochanteric nailDevice
Also called Proximal Femoral Nail Antirotation (Synthes), Titanium Trochanteric Fixation Nail (Synthes), Gamma Trochanteric Nail (Stryker)
Intertrochanteric nail (PFNA, TFN, GN)
| Study group | Role | What they receive |
|---|---|---|
| Proximal femur locking plate | Active comparator | Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc) Receives: Device: Proximal femur locking plate |
| Trochanteric nail | Other | Treatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN) Receives: Device: Intertrochanteric nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one year
Secondary outcomes (10)
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.
Measured: one year
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]).
Measured: one year
Patient satisfaction with the Visual Analogue Scale
Satisfaction measured with the VAS
Measured: one year
Abductor muscle function with the Trendelenburg sign analysis
Abductor muscle function test
Measured: one year
Surgical details
Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience.
Measured: Initial hospitalization
Local complications
Local complication will be recorded and categorized:
Implant / surgery complications, Bone / fracture complications, Soft tissue / wound complications.
Measured: one year
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.
Measured: one year
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.
Measured: one year
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.
Measured: Initial hospitalization
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMay 2011
- Primary completionJun 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse Oblique Intertrochanteric FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beate P. Hanson, MD, Study director, AO Clinical Investigation and Documentation, Davos, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128868
- Sponsor's protocol ID
- PF LCPs vs Trochanteric Nail
- Status last verified
- Aug 2020
- First submitted
- 20 May 2010
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01128868
- Acronym / sponsor ID
- PF LCPs vs Trochanteric Nail
- Keywords
- Reverse oblique intertrochanteric fractures, Reverse oblique subtrochanteric fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal femur locking plate | Active comparator | Device: Proximal femur locking plateTreatment of reverse oblique intertrochanteric or subtrochanteric fractures with a Proximal Femur Locking Compression Plate (PF-LCP, PF-LCP Hook Plate, PeriLoc) |
| Trochanteric nail | Other | Device: Intertrochanteric nailTreatment of reverse oblique intertrochanteric or subtrochanteric fractures with Trochanteric Nails (PFNA, TFN, GN) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal femur locking plateAlso: LCP Proximal Femur Plate (Synthes), LCP Proximal Femur Hook Plate (Synthes), PeriLoc Periarticular Locked Plating System (Smith & Nephew)Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc) | Device | Proximal femur locking plate |
| Intertrochanteric nailAlso: Proximal Femoral Nail Antirotation (Synthes), Titanium Trochanteric Fixation Nail (Synthes), Gamma Trochanteric Nail (Stryker)Intertrochanteric nail (PFNA, TFN, GN) | Device | Trochanteric nail |
Primary outcome
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
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).
10 secondary outcomes
Patient outcome
Time frame: one year
Pain scores on the Visual Analog Scale
Time frame: one year
Patient satisfaction with the Visual Analogue Scale
Time frame: one year
Abductor muscle function with the Trendelenburg sign analysis
Time frame: one year
Surgical details
Time frame: Initial hospitalization
Local complications
Time frame: one year
Revision rate
Time frame: one year
Systemic or general complications
Time frame: one year
Exploration of prognostic factors for the occurrence of complications, using the Fracture Risk Assessment Tool (FRAX)
Time frame: Initial hospitalization
Quality of reduction
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beate P. Hanson, MD study director
AO Clinical Investigation and Documentation, Davos, Switzerland
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal femur locking plate and Intertrochanteric nail in people with Reverse Oblique Intertrochanteric Fractures and Reverse Oblique Subtrochanteric Fractures, run by AO Clinical Investigation and Publishing Documentation at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.