Radiological evaluation of CT based vs MRI based Signature* for total knee arthroplasty

Completed

Conditions: knee wear
osteoarthritis
10005944

Registration Number: NL-OMON40504

Lead Sponsor: Orbis Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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.
*High need to obtain pain relief and improve function,
-Body-mass-index (BMI) <35
-Ablility and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
-Consent form read, understood and signed by patient.

Exclusion Criteria

-Active infection in knee
-General infection
-Distant foci of infections which may spread to the implant site
-Failure of previous knee joint replacement
-Pregnancy
-Previous major knee surgery, except for arthroscopic meniscectomy.
-Metal near knee joint (MRI-scan not possible)
-Not able or willing to undergo MRI-scan or CT-scan
-Reumatoid arthritis
-Non-correctable varus axis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outliers in alignment of the femoral and tibial prosthesis in the frontal<br /><br>plane, measured on radographs made 6 weeks after operation and compared between<br /><br>the CT-based Signature* procedure and the standard MRI-based Signature*<br /><br>Occurrence (and percentage) of outliers in alignment in the frontal, sagittal<br /><br>and horizontal plane of femoral and tibial components.<br /><br>Occurrence (and percentage) of outliers in alignment of the mechanical axis of<br /><br>the leg.<br /><br>Difference in thickness of the in vivo inserted polyethylene compared to<br /><br>pre-operatively calculated thickness of this<br /><br>insert.<br /><br>Accuracy of the guides</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Operation time<br /><br>Fit, form and practical use of the Signature* alignment guides.<br /><br>Needed change of plans per-operative: change of size of prosthesis, conversion<br /><br>Signature procedure to conventional<br /><br>procedure for any reason</p><br>