Signature* Personalized Patient Care in Partial Knee Arthroplasty, Comparing preoperatively planned alignment with postoperative achieved alignment, A prospective shape-matching study

Recruiting

Conditions: joint wear
osteoarthritis of the medial knee compartment
10023213
10005944

Registration Number: NL-OMON37439

Lead Sponsor: Orbis Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

•Painfull and disabled knee joint resulting from osteoarthritis of the medial knee compartment.
•High need to obtain pain relief and improve function,
-Above 18 years old (full skeletal maturity).
-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

-Patients with osteoarthritis of more than only the medial knee compartment
-Active infection in knee
-General infection
-Distant foci of infections which may spread to the implant site
-Failure of previous 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 and CT-scan
-Reumatoid arthritis
-Extension deficit of more than 15 degrees
-Flexion less than 110 degrees
-Non-correctable varus axis
-Cruciate ligament insufficiency

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the preoperatively planned, computer-based Signature* alignment plan<br /><br>with the actual achieved alignment in the<br /><br>frontal, coronal and sagittal plane in vivo postoperatively of both the femur<br /><br>and tibia components of the total knee arthroplasty.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the occurrence (and percentage) of outliers in alignment in the<br /><br>frontal, sagittal and horizontal plane of femoral<br /><br>and tibial components.<br /><br>To determine the occurrence (and percentage) of outliers in alignment of the<br /><br>mechanical axis of the leg.<br /><br>Verify the fit, form and practical use of the Signature* alignment guides.<br /><br>Verify to what extend the thickness of the in vivo inserted polyethylene<br /><br>corresponds with the pre-operatively calculated<br /><br>thickness of this insert.</p><br>