A prospective, multi-centre randomised comparative study ofimplant fit, clinical outcomes and satisfaction with the Stryker Accolade II Hip Stem compared to the Corail Hip Stem
Phase 4
Completed
- Conditions
- Total Hip Replacement SurgeryNon-Inflammatory Degenerative Joint Disease of the HipMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12613000629730
- Lead Sponsor
- Stryker Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 304
Inclusion Criteria
1.Patient are male or non-pregnant females requiring a cementless THR for non-inflammatory degenerative joint disease of the hip.
2.Must be older than 18 years
Exclusion Criteria
1. Patient has a cognitive impairment, an intellectual disability or a mental illness
2. People whose primary language is other than English
3. Pregnant Women
4. Children and or/young people (ie. <18 years)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To compare the pre-operative plan with the intraoperative size preferance of femoral stem in patients randomised to either Accolade II or Corail femoral stem. <br>Radiolographs and surgical data[Pre-Operative, Intra-Operative];2. To determine clinical outcomes of THR, using the Oxford Hip Score, in patients receiving the Accolade II femoral stem compared to Corail femoral stem<br>[Pre-Operative, Post - Operative - 6 weeks<br>6 months, 12 months, 24 months];NZ iDXA/Anato stem substudy primary outcome: To compare the % differences in pre-operative (BMD) over time, in the regions of interest (ROIs) based on the Gruen zones, around the Accolade II, Corail or Anato stems. This percent change in BMD will be measured using an iDXA machine.[Pre-op, 6 week, 12 mnth, 24 mth]
- Secondary Outcome Measures
Name Time Method