None listed
Conditions
Brief summary
Neck of femur fractures are common, and generally treated with surgery. One of the most commonly used devices is an intra-medullary nail. There are numerous devices on the market, all with individual data, but there is very little comparative evidence. The majority of IM nail designs have a proximal ‘lag screw’ which can be used in either static or dynamic modes. There is no published evidence regarding which of these modes is better. We aim to recruit a total of 900 trauma patients aged over 60, who will be randomly assigned to receive one of 2 different nail designs, as well as 2 different locking modes. We will then follow the patients for a minimum of 6 months (or until the fracture has healed) and compare the clinical and functional outcomes of the groups. Of the 900 patients randomised into the study, the first 100 from each of the three randomised arms of the study will be selected for the observational element of the study involving gait analysis and activity monitoring. We hypothesize that there is a difference in clinical and functional outcomes between patients managed with the Gamma or INTERTAN nailing systems, in either locking mode.
Interventions
Neck of femur fractures are common, and generally treated with surgery. One of the commonly used devices is an intramedullary (IM) nail with proximal fixation extending into the femoral head. There are numerous devices on the market, all with individual data, but there is very little comparative evidence. The majority of IM nail designs have a proximal ‘lag screw’ which can be used in either static or dynamic modes. There is no published evidence regarding which of these modes is better.
The s
Neck of femur fractures are common, and generally treated with surgery. One of the commonly used devices is an intramedullary (IM) nail with proximal fixation extending into the femoral head. There are numerous devices on the market, all with individual data, but there is very little comparative evidence. The majority of IM nail designs have a proximal ‘lag screw’ which can be used in either static or dynamic modes. There is no published evidence regarding which of these modes is better. The study will follow a prospective randomized controlled design at the Royal Adelaide Hospital, with patients also recruited at Flinders Medical Centre, The Queen Elizabeth Hospital and Lyell McEwin Hospital (South Australia). We aim to recruit a total of 900 trauma patients aged over 60 years, who will be randomly assigned to receive one of two different femoral nail designs (both designs are current standards on the market), as well as two different locking modes. Patients will be randomised to receive either the INTERTAN™ nail (Locked proximally), the INTERTAN™ nail (Unlocked proximally), or a Gamma nail (Unlocked proximally) for fracture fixation, after a decision to undergo surgical treatment for their fracture has already been made. Patients who refuse to consent to the study will not be included in the study and routine clinical practice will be carried out. For patients consenting to the study, we will follow the patients for a minimum of six months (or until the fracture has healed) and compare the outcomes of the groups. The patients will undergo surgery at the earliest opportunity in line with local protocols and surgery will be carried out by the normal surgical team at the hospital for that day – no changes will be made to timings or personnel involved. The device and mode of locking will be as per the randomization outcome. Post operatively all patients will be mobilised fully weight bearing as able, and follow a standard physiotherapy / rehabilitation regime. Each surgery will be conducted by an orthopaedic surgeon and will take approximately 30-45 minutes. Fidelity of the procedure will be assessed via radiographic image intensifier via the normal orthopaedic surgical team operating on that day.
Sponsors
A/Prof Mark Rickman
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Traumatic extracapsular hip fracture 2. Closed injury 3. Patient aged over 60 years 4. Ability to be followed for up to six months 5. Presentation to hospital within 14 days of injury
Exclusion criteria
1. Patients with concomitant injuries affecting treatment and rehabilitation of the affected limb. 2. Patients with associated neurovascular injuries requiring immediate surgery 3. Patients where consent is refused 4. Patient with limited English proficiency including family members
Outcome results
None listed