None listed
Conditions
Brief summary
Study Rationale: The current choice of treatment for intertrochanteric fracture is the Dynamic Hip Screw. Technical and mechanical failure of this device currently occurs in 6-18% of all cases. Better understanding, more validated data and the need for better treatment regarding intertrochanteric fracture is necessary. "Prospective studies comparing the trochanteric nail, with and without distal interlocking to the sliding/dynamic hip screw are warranted". Study Aim: The purpose of this prospective randomised study is to compare the intramedullary gamma nail to the dynamic hip screw in regards to functional outcome. Specific Aims: The aim of this study is to compare the results of the surgical intervention with parameters such as operative time, blood loss, operative complications and cost for each device. In the post operative period the functional results of patients will be compared with initial mobilisation and discharge through to long term function and return to activities of daily living. The degree of fracture collapse will be recorded and compared to function. Long term fracture union will also be assessed.
Interventions
Gamma 3 Trochanteric Nail:
The Gamma3 Short Intramedullary Nailing System was designed to facilitate minimally invasive surgery and reduce Operation time down to a minimum by the aid of using new instrumentation and an optimized surgical technique. The nails have a proximal diameter of 15.5mm to help minimize the incision length required for minimally invasive surgery. The Gamma3 nail offers the same biomechanical strength and cutout resistance as the well established Trochanteric and Long Gamm
Gamma 3 Trochanteric Nail: The Gamma3 Short Intramedullary Nailing System was designed to facilitate minimally invasive surgery and reduce Operation time down to a minimum by the aid of using new instrumentation and an optimized surgical technique. The nails have a proximal diameter of 15.5mm to help minimize the incision length required for minimally invasive surgery. The Gamma3 nail offers the same biomechanical strength and cutout resistance as the well established Trochanteric and Long Gamma Nails. The new lag screw shape has been improved in the area of the thread and the cutting flutes at the tip of the screw. The new design offers superior cutting behavior during lag screw insertion, providing low insertion torque. The new thread design offers grip in the cancellous bone of the femoral head and strong resistance against cut out. The 5mm distal locking screws are currently used in the Gamma-Ti and T2 intramedullary nailing systems. The gamma nail system will remain in the patients femur permanently.This is a once off treatment
Sponsors
Rob Molnar
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
A non pathological intertrochanteric hip fracture. Fracture classified as association for osteosynthesis/orthopaedic trauma association (AO/OTA) 31-A1 or A2 or a stable fracture after reduction. Experienced a low-energy injury only.
Exclusion criteria
Fracture classified as association for osteosynthesis/orthopaedic trauma association (AO/OTA) 31A-A3. Unstable fracture after reduction. A pathologic fracture. A fracture associated with polytrauma. Had previous ipsilateral hip or femur surgery. A fracture with extension 5cm distal to the inferior border of the lesser trochanter. An associated neurovascular injury with objective neurological findings on physical examination. An inability to comply with follow up procedures (including inability to read and fill out forms). A medical contraindication to surgery and or anesthesia (such as heart disease, renal failure or active chemotherapy). Lack of consent.
Outcome results
None listed