Reverse Oblique Intertrochanteric Fractures Clinical Trial
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
| Verified date | August 2020 |
| Source | AO Innovation Translation Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | July 2014 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
| Switzerland | Cantonal Hospital Chur | Chur | |
| Switzerland | Cantonal Hospital Lucerne | Lucerne |
| Lead Sponsor | Collaborator |
|---|---|
| AO Clinical Investigation and Publishing Documentation |
Australia, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | one year | |
| Secondary | 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. |
one year | |
| Secondary | 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]). | one year | |
| Secondary | Patient satisfaction with the Visual Analogue Scale | Satisfaction measured with the VAS | one year | |
| Secondary | Abductor muscle function with the Trendelenburg sign analysis | Abductor muscle function test | one year | |
| Secondary | Surgical details | Skin-to-skin time, Fluoroscopy time, Blood loss, Blood transfusions, Surgeons experience. | Initial hospitalization | |
| Secondary | Local complications | Local complication will be recorded and categorized: Implant / surgery complications, Bone / fracture complications, Soft tissue / wound complications. |
one year | |
| Secondary | 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. | one year | |
| Secondary | 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. | one year | |
| Secondary | 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. |
Initial hospitalization | |
| Secondary | 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. | one year |