Evaluation of the TruMatch® System in Knee Prosthetic Surgery

Good alignment after a TKR leads to faster rehabilitation, better clinical outcomes and lower revision rate. A correct rotational (axial) alignment reduces patellofemoral complications, polyethylene wear and unexplained knee pain.

A randomized controlled study is conducted to test if to use the TruMatch® (DePuy Johnson & Johnson, Warsaw, Indiana) patient specific instrumentation reduces the number of patients presenting femorotibial mismatch.

Secondary goals are to compare:

• alignment in the coronal, sagittal and axial plane of the femoral component;
• alignment in the coronal and sagittal plane of the tibial component;
• number of recuts during surgery and surgeon's adherence to planning;
• blood loss;
• clinical outcome after two months using the Oxford Knee Score (OKS).

After having signed informed consent, patients will be randomized in 2 groups preoperatively. A long-leg CT scan, according to manufacturer's instructions, will be performed on patients randomized to the TruMatch® group.

Haemoglobin and haematocrit will be recorded pre- and postoperatively.

Two months after surgery a knee CT-scan, anteroposterior and laterolateral scanograms will be performed on all patients, and OKS will be recorded.

Inclusion criteria

• Age > 40, <80
• Indication for TKR
• Surgical indication for Attune®, posterior stabilized, fixed bearing TKR
• Patients signed written informed consent

Exclusion criteria

• Age > 80, < 40
• TKR revision surgery
• Metal devices within 8 cm from knee articular surfaces
• Fixed knee deformities greater than 15° in varus, valgus, flexion or tibial slope.
• Knee ankylosis
• Previous tibial osteotomy surgery
• Informed consent not accepted
• Serious comorbidity
• Active infections
• Pregnant or breastfeeding women