None listed
Conditions
Brief summary
Fractured neck of femur (FNF) is a common condition, affecting 25,000 Australians per annum. Total hip arthroplasty (THA), which involves replacing the ball and socket of the hip joint, is the current standard of care for fractured neck of femur in community-dwelling patients with minimal co-morbidities. However, despite superior pain and functional scores compared to the alternative treatment, partial hip replacement (hemiarthroplasty), THA exposes patients to an increased risk of prosthesis dislocation. Prosthesis dislocation involves separation of the prosthetic head and acetabular cup, and may require a patient to undergo revision THA, a procedure associated with increased costs and morbidity. Dual mobility cups (DMC) are an alternative THA design in common use in Australia, and are hypothesised to reduce the risk of dislocation. This trial will compare the outcomes of conventional THA versus DMCs in the FNF population.
Interventions
Dual mobility cup (DMC) has been proposed as an alternative, novel design for Total Hip Arthoplasty (THA) that is purported to reduce the risk of dislocation in high-risk populations such as femoral neck fractures. This is achieved by use of a larger head-to-neck ratio and jump distance (i.e. vertical or inferior head displacement required for dislocation) that approximates the size of the natural femoral head allowing an increased range of motion in all directions before dislocation occurs.
Th
Dual mobility cup (DMC) has been proposed as an alternative, novel design for Total Hip Arthoplasty (THA) that is purported to reduce the risk of dislocation in high-risk populations such as femoral neck fractures. This is achieved by use of a larger head-to-neck ratio and jump distance (i.e. vertical or inferior head displacement required for dislocation) that approximates the size of the natural femoral head allowing an increased range of motion in all directions before dislocation occurs. The surgery to implant the DMC is the same procedure as implanting a conventional THA, and takes approximately 90 minutes. The only aspect of the procedure that changes is the type of acetabular ('hip socket') liner inserted. The procedure is performed by an Orthopaedic surgeon. Adherence to the study protocol will be determined using standard Australian Orthopaedic Association National Joint Replacement Registry data (prosthesis details). Both primary and revision surgeries recorded by the AOANJRR are validated by cross-referencing with hospital-level data and unmatched revisions are verified by contacting individual sites. The study will use a cluster-randomised crossover design. Clusters will consist of individual hospitals. Clusters will be randomised to either the intervention or the comparator. Sites will crossover to the alternate procedure once 16 patients have been recruited to their originally allocated study arm. The number of patients per cluster may vary according to recruitment speeds. For example, a low volume recruitment site may crossover after 8 patients have been recruited, and a high volume recruiment site may crossover after 24 patients have been recruited. This will be accounted for in statistical analyses for an average cluster size of 16 patients per study arm, with 32 patients total anticipated on average per site.
Sponsors
Australian Orthopaedic Association
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Displaced femoral neck fracture suitable for conventional THA (e.g. no pre-existing deformity requiring custom or non-standard protheses) 2. Aged 50 years or older 3. Patient meets Australia New Zealand Hip Fracture Guidelines for management of a displaced intracapsular hip fracture with a total hip replacement: 4. Able to walk independently out of doors with no more than use of a stick prior to the fracture 5. Not cognitively impaired 6. Medically fit for anaesthesia and the procedure
Exclusion criteria
1. Dementia or other significant cognitive impairment 2. Resident of a permanent residential aged care facility 3. Pathological fracture due to tumour
Outcome results
None listed