None listed
Conditions
Brief summary
A 2 year clinical study to compare the clinical results of a new design to existing designs, of an acetabular hip cup aimed to resist dislocation while allowing normal motion, after total hip replacement surgery for patients 50 and over suffering a fracture of the neck of the femur. The study hypothesis is that at a minimum of 2 years, the new design is at least as safe and effective as existing standard total hip cups used to treat femoral neck fractures, and the new design reduces the risk of revision for dislocation in the first year versus those standard cups.
Interventions
Following a fractured neck of femur, patients agreeing to participate in the study will undergo surgery by a trained Orthopaedic surgeon for implantation of a polyethylene liner within a cobalt-chrome liner, which is inserted into a titanium outer shell fitted into the acetabulum. The inner liner has a containment mechanism that provides full movement with secure constraint at the terminal range. This is mated with a new or existing standard femoral stem and head that completes the joint replace
Following a fractured neck of femur, patients agreeing to participate in the study will undergo surgery by a trained Orthopaedic surgeon for implantation of a polyethylene liner within a cobalt-chrome liner, which is inserted into a titanium outer shell fitted into the acetabulum. The inner liner has a containment mechanism that provides full movement with secure constraint at the terminal range. This is mated with a new or existing standard femoral stem and head that completes the joint replacement. This is a single procedure taking approximately 1 to 2 hours. Patients will be assessed immediately post-operatively and subsequently their medical records will be further reviewed and assessed at 30 days, 1 year and 2 years.
Sponsors
R R Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with displaced femoral neck fracture suitable for standard total hip arthroplasty.
Exclusion criteria
Inability to walk independently pre-fracture. Dementia or significant cognitive impairment. Permanent resident of aged care facility. Pathological femoral fracture.
Outcome results
None listed