Patients who require TKA as a result of gonartrosis Preservation, ACL, PCL, Bi-cruciate, TKA
Conditions
Interventions
The Vanguard™ XP total knee system is a cruciate retaining design that allows for the posterior cruciate ligament (PCL) and the anterior cruciate ligament (ACL) to be preserved while incorporating geo
Sponsors
Dep. of Orthopedic Surgery, Atrium-Orbis Medical Centre, location Sittard-Geleen.
Maastricht University, Dep. Human Movement Science
Eligibility
Inclusion criteria
Inclusion criteria: •Cemented application of components •Patients with pre-existing contra lateral knee surgery •Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved •Correction of varus, valgus, or posttraumatic deformity •Sufficient soft tissue surrounding the knee, including the ACL and PCL (based on MRI) •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: •Cement less application of components •BMI greater than or equal to 35 •Use of Anterior Stabilized Bearings or Posterior Stabilized Bearings •Patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees •Correction or revision of previous joint replacement procedure on index knee •Sepsis •Osteomyelitis •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) •Rheumatoid arthritis •Extension deficit of more than 15 degrees •Flexion less than 100 degrees. •Non-correctable varus axis •Cruciate ligament insufficiency (based on MRI) •Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram •Uncooperative patient or patient with neurological disorders who is incapable of following directions •Osteoporosis •Metabolic disorders which may impair bone formation •Osteomalacia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rotational degrees of freedom of the tibial implant, measured with 3-D motion analysis after operation and compared between the XP tibia implant and CR conventional tibia implant operated with either the MRI-based Signature™ guide or the Conventional alignment | — |
Secondary
| Measure | Time frame |
|---|---|
| •Comparing operative, clinical and radiological outcome of the operative procedure with Signature™ and/or the conventional standard intramedullary alignment guides. •Verify the fit, form and practical use of the Signature™ alignment guides. •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. •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. •Verify to what extend the thickness of the in vivo inserted polyethylene corresponds with the pre-operatively calculated thickness of this insert. | — |
Contacts
Public ContactM.G.M. Schotanus
Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1
Outcome results
None listed