A Multi-centre, Prospective, Clinical Outcomes Study to evaluate the MPRES Stem following primary Total Hip Arthroplasty
Not Applicable
- Conditions
- Degenerative osteoarthritisTotal Hip ArthroplastyMusculoskeletal - OsteoarthritisSurgery - Other surgery
- Registration Number
- ACTRN12622001141730
- Lead Sponsor
- Medacta Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 280
Inclusion Criteria
•Male & Females 18-75 years old
•Use of the non TGA approved (pre-market) Medacta MPRES femoral stem prosthesis.
• Ability to give informed consent.
•Qualify for primary total hip arthroplasty surgery with cementless fixation
•Primary diagnosis of non-Inflammatory Degenerative Joint Disease
•Skeletally mature
•Good bone density
•BMI less than or equal to 40.
Exclusion Criteria
•Previous hip replacement or fusion on affected side
•Active infection in the affected joint
•Intra-articular fracture
•Neuromuscular or neurosensory deficiency
•Diagnosed metabolic disorder which may impair bone formation or bone quality
•Immunologically suppressed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine MPRES Femoral Stem survivorship (efficacy) at 2, 5 and 10 years post-operatively compared to all other cementless femoral stems. Survivorship will be assessed by determining the time to first revision surgery required following implantation of the MPRES femoral stem device. These estimates will be calculated using Kaplan-Meier estimates of survivorship. The survivorship data will be sourced and compared to the best performing mini stems currently on the market using the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR).[1 year, 2-years (primary time-point), 5 and 10 years post-operatively]
- Secondary Outcome Measures
Name Time Method