Randomized controlled trial to compare functional outcomes between LOcking compression Plates and Retrograde Intramedullary Nails in distal femur fractures

The treatment under investigation is retrograde intramedullary nailing. RIMN requires less extensive dissection and in a biomechanical study comparing RIMN with LCP and dynamic condylar screw, RIMN was found to have greatest stability for type 33A fractures. This method is routinely used for the stabilization of femoral fractures, including distal extraarticular ones. A 3- to 4-cm incision is done through either a tendon split or a parapatellar arthrotomy. The nail is inserted in the intercondylar notch just anterior to the femoral attachment of the posterior cruciate ligament. Then a guide pin is inserted in line with the femoral shaft to ensure restoration of coronal plane alignment on both radiographic views. Next the entry reamer is used to open the metaphyseal segment. Cannulated soft tissue sleeves are used to prevent injury to the patellar tendon and articular surface of the patella. Once the fracture is reduced, the guide pin is inserted into the medullary canal, as far as approximately 12-14 cm proximal to the fracture zone. Reaming is done. Then drive the nail over the guide pin after confirmation of size and diameter of the nail. For retrograde femoral nailing to achieve adequate fracture stabilization, the fracture should be at least 6 cm from the joint line to achieve distal locking with screws. Distally, fix both screw holes, while proximally use one screw hole for fixation. Before the wound closure, perform thorough irrigation of the knee wound in order to minimize the risk of infection and to remove any debris from the joint. End the procedure with the closure of the tendon (as necessary), the deep tissues and the skin. Orthopedic surgeon will perform the intervention and the process will take around 45 min to 1 hour. Study schedule and randomization process will be diligently followed according to the study protocol. Every eligible patient will be randomly allocated to either LCP or RIMN. The randomization list will be prepared using software by an independent researcher using random block sizes of 2, 4 and 6. This randomization list will not be available to those who enrol participants (study team members) or assign interventions (treating physician) to maintain concealment. Once the patient is in the operating theatre and is given anaesthesia for surgery, a telephone call will be made to the independent researcher to ask for the treatment allocation. Neither the patient nor the surgeon can be blinded due to the difference in implants and wound patterns. Assessor(s)=physiotherapists will be blinded by covering the knees of the patient during assessment of functional score.