Proximal Femur Locking Compression Plates Versus Trochanteric Nails

AO Clinical Investigation and Publishing Documentation

Status: Completed

Conditions: Reverse Oblique Intertrochanteric Fractures; Reverse Oblique Subtrochanteric Fractures

Treatments: Device: Proximal femur locking plate; Device: Intertrochanteric nail

Study type: Interventional

Funder types: Other

Identifiers

NCT01128868

PF LCPs vs Trochanteric Nail

Details and patient eligibility

About

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).

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Proximal femur locking plate

Active Comparator group

Description:

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

Treatment:

Device: Proximal femur locking plate

Trochanteric nail

Other group

Description:

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

Treatment:

Device: Intertrochanteric nail