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

Inclusion Criteria7

Age =/>60 years
Males and females
Capable of providing prospective informed consent
Acute distal femur fractures
Hip periprosthetic fractures and knee periprosthetic fractures
All fractures suitable for distal femur locking plate fixation
Informed patient consent available from patient or legal guardian

Exclusion Criteria14

The patient has a Glasgow Coma Scale score of less than 15 at the time of informed consent;
Patients below the age of 60 years;
Patients with limited life expectancy (likely unable to complete follow-up program);
The anticipated treatment plan for the fracture within the first 12 weeks after the surgical fixation includes procedures to promote fracture healing (such as the use of autogenous bone graft, allograft, bone graft substitute, use of ultrasound, magnetic field, or electrical stimulation).
The patient has persistent compartment syndrome or compartment syndrome with clinically significant neurovascular residua in the fractured limb under study.
The femoral fracture is pathological (except if due to idiopathic osteoporosis);
History of the heterotopic ossification at any site;
History of malignancy, radiotherapy, or chemotherapy for malignancy within the past two years except for basal cell carcinoma of the skin;
The patient is not willing to return for required follow-up visits;
Patients unable to comply with the rehabilitation and follow up programme;
Pre-morbid non-ambulatory patients;
Open fracture patterns (Gustilo garde III open fractures);
Periprosthetic fractures Vancouver Type B1, B2 & B3 at the hip joint & Rorabeck type 3
The patient has any other condition that, in the judgement of the Investigator, would prohibit the patient from participating in the study

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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.