RecruitingACTRN12617000493347

Distal Femur Fracture Healing in the Elderly Using Far Cortical Locking Screws.

Does far cortical locking improve fracture healing in elderly patients distal femur fractures: A randomised, controlled, prospective, multi-centre study

Sponsor

Royal Perth Hospital (Professor Markus Kuster)

Enrollment

100 participants

Start Date

Oct 29, 2016

Study Type

Interventional

Conditions

Distal Femur Fracture

Summary

There is currently no literature on the use of far cortical locking screws when compared to standard locking screw constructs in human patients, we know of one RCT currently in progress with Canadian Orthopaedic Trauma Society (COTS). The COTS study will look at the treatment of distal femoral fractures using Zimmer MotionLoc screws versus standard locking screws in all age groups and include high impact trauma cases. This study proposes to look more specifically at callus formation and fracture healing in older patients treated with FCL versus standard locking plate fixation, with the inclusion of peri-prosthetic distal femoral fractures. Fixation in these fractures is generally more challenging and therefore it is of interest to establish whether FCL is a valuable option also for these cases. Fracture healing by secondary healing with bridging callus formation will be the principal measurable outcome to demonstrate the potential differences in fixation between FCL and standard locking screws.

Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of surgical screws used to fix broken bones just above the knee (distal femur fractures) in older patients: far cortical locking (FCL) screws and standard locking screws. Researchers want to find out whether FCL screws lead to better bone healing, particularly in patients with fragile bones or fractures around a hip or knee implant. You may be eligible if: - You are 60 years of age or older - You have had an acute distal femur fracture, or a fracture around a hip or knee implant - Your fracture is suitable for fixation with a distal femur locking plate - You are able to provide informed consent (or your guardian can) You may NOT be eligible if: - You are under 60 years of age - Your fracture is caused by a tumour (unless due to osteoporosis) - You have a Glasgow Coma Scale score below 15 at time of consent - You have had a malignancy requiring treatment in the last 2 years (excluding skin cancer) - You are not able or willing to complete the follow-up program - You are not ambulatory (able to walk) before the fracture Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a prospective, randomised, controlled, double blinded (patient and investigator), multi-centre trial assessing bone healing of distal femoral fractures in the elderly population comparing Far

This is a prospective, randomised, controlled, double blinded (patient and investigator), multi-centre trial assessing bone healing of distal femoral fractures in the elderly population comparing Far Cortical Locking Screws (FCL) to standard locking screws (SL). FCL screws engage in the plate and the far cortex of the bone allowing a small amount of motion at the near cortex of fixation whereas the standard locking screws engage in the plate and both near and far cortices of the bone. The study population will comprise patients over the age of 60 years who have acute distal femoral fractures suitable for distal femoral locking plate fixation using a NCB fracture plate. A total of 100 patients will be enrolled in the study. Each patient will undergo standard surgical locking plate fixation of the distal femoral fracture using either 3-4 FCL screws for fixation of the proximal femoral fragment in the intervention group, or 3-4 standard NCB locking screws (NCB screw, Zimmer) for fixation of the proximal femoral fragment in the control group. The number of screws is predetermined by the length of the fracture and the treating physician and must be a minimum of 3 screws. The technique of bridged plating will be applied to both groups. The procedure is performed by an orthopaedic surgeon for both groups.