A Prospective Randomised Trial comparing Post-operative knee alignment following total knee replacement using patient specific knee instrumentation based on either CT or MRI.
Not Applicable
- Conditions
- Musculoskeletal Diseases
- Registration Number
- PACTR202009612835052
- Lead Sponsor
- Zimmer GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
1.Patients suitable for primary Total Knee Replacement
2.Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
a.Osteoarthritis
b.Avascular necrosis
c.Inflammatory Arthritis
d.Traumatic arthritis
3.Patients aged over 18 and up to 80 years of age
4.Patients with limited co-morbidity – ASA I – III
5.Patients must be able to understand instructions and be willing to return for follow-up
Exclusion Criteria
1.Patients with significant co-morbidity - ASA IV - V
2.Dementia and inability to understand and follow instructions
3.Neurological conditions affecting moment
4.Patients who are intolerant of placement in a CT or MRI gantry because of claustrophobia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Coronal and sagittal knee alignment following total knee replacement using PSI based on either CT scan or MRI.
- Secondary Outcome Measures
Name Time Method 1.Oxford Knee Score at each post-operative visit.<br>2.Knee Society Score pre and post-operatively.<br>3.Knee injury and Osteoarthritis Outcome Score (KOOS). <br>4.Radiographic analysis at each post-operative visit. <br>5.Complications (including revisions/removals).<br>6.Clinical Composite Success<br>