Radiological evaluation of CT vs MRI based Signature™ for total knee arthroplastyA Prospective, Randomized Study
Recruiting
- Conditions
- Patients who require TKA as a result of osteoarthritis of the knee and are candidates for the Vanguard TKA system.
- Registration Number
- NL-OMON23068
- Lead Sponsor
- Orbis
- Brief Summary
Schotanus, M. G. M., et al. "A radiological analysis of the difference between MRI-and CT-based patient-specific matched guides for total knee arthroplasty from the same manufacturer." Bone Joint J 98.6 (2016): 786-792.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
Patients scheduled to undergo primary TKA replacement with any of the following indications
•Painful and disabled knee joint resulting from osteoarthritis.
Exclusion Criteria
-Active infection in knee
-General infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Outliers in alignment of the femoral and tibial prosthesis in the frontal plane, measured on radiographs made 6 weeks after operation and compared between the CT-based Signature™ procedure and the standard MRI-based Signature™
- Secondary Outcome Measures
Name Time Method •Fit and practical use of the guides<br /><br>•Needed change of plans and reasons for changes<br /><br>•Occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components.<br /><br>•Occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. <br /><br>•Difference in thickness between the in vivo inserted polyethylene and the pre-operatively calculated thickness of this insert.<br /><br>•Accurateness of guides: deviations from pre-operative digital plan.<br>