None listed
Conditions
Brief summary
This is a prospective, multi-centre, clinical study using a product that has been registered for use in Australia by the TGA. The primary purpose of the study is to measure micro-movement of a cementless total hip replacement implant within the bone at timepoints up to three years. The micro-movement (if any) will be measured using X-Rays. 222 participants will be recruited and will be followed up for a period of three years. Quality of Life will also be analysed using two questionnaires.
Interventions
Primary total hip replacement with an uncemented femoral stem. The intervention is the hip replacement surgery which will be carried out by a suitably qualified and experienced orthopaedic surgeon. The intervention will be delivered once only for each participant and will take place in an operating theatre within a hospital setting
Sponsors
MAC Surgical
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants with symptomatic arthritis who are candidates for a primary total hip replacement with an uncemented femoral stem as determined jointly by the surgeon and the patient Age - 75 years or less Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up period
Exclusion criteria
Patients with rheumatoid arthritis Patients with a history of active infection Patients with conditions or medications associated with osteoporosis or osteopenia Pregnant women or those seeking to become pregnant
Outcome results
None listed