Partial knee arthroplasty, accuracy, CT controlled, patient specific guides
Conditions
Interventions
patient specific femoral and tibial positioning guides are developed from MRI. The guides are made of polyamide and are disposable. The system fits the femoral and tibial components independently, is
Sponsors
Department of Orthopedic Surgery
Orbis Medisch Centrum, Sittard-Geleen,
The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: -Patients scheduled to undergo primary UKA replacement with any of the following indications - Painful 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 -Ability 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the preoperatively planned, computer-based Signature™ alignment plan with the actual achieved alignment in the frontal, coronal and sagittal plane in vivo postoperatively of both the femur and tibia components of the partial knee arthroplasty. | — |
Secondary
| Measure | Time frame |
|---|---|
| Verify the fit, form and practical use of the Signature™ alignment guides. Shape-matching: To determine the occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. Outliers are defined as deviations > 3 degrees from preoperative planning. Shape-matching:To determine the occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. Outliers are defined as deviations > 3 degrees from preoperative planning. Shape-matching: Verify to what extend the thickness of the in vivo inserted polyethylene corresponds with the pre-operatively calculated thickness of this insert. Shape matching: To compare the pre operatively planned alignment of the prosthesis as determined by software and based on the MRI-scan with the actual postoperative alignment of the prosthesis placed with Signature™ in the frontal, transverse and sagittal plane (accurateness of the guides). | — |
Contacts
Public ContactM.G.M. Schotanus
Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1
Outcome results
None listed