Patients who require TKA as a result of osteoarthritis of the knee and are candidates for the Vanguard TKA system.
Conditions
Interventions
TKA aligned either with the CT based Signature™ or the MRI based Signature™ alignment guide.
Sponsors
Orbis
Eligibility
Inclusion criteria
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 - 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: - 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 or CT-scan - Rheumatoid arthritis - Non-correctable varus axis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •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
| Measure | Time frame |
|---|---|
| • Fit and practical use of the guides • Needed change of plans and reasons for changes • Occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. • Occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. • Difference in thickness between the in vivo inserted polyethylene and the pre-operatively calculated thickness of this insert. • Accurateness of guides: deviations from pre-operative digital plan. | — |
Contacts
Public ContactM.G.M. Schotanus
Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1
Outcome results
None listed