NCT01876654

Evaluation of the TruMatch® System in Knee Prosthetic Surgery

Evaluation of the TruMatch® Personalized Solutions System in Knee Prosthetic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Patient specific instrumentation is an alternative to conventional intra- and extra-medullary guides to perform the femoral and tibial cuts in total knee replacement (TKR). This instrumentation could provide a better alignment of a TKR, reduce blood losses and operative time, and improve clinical outcomes. The primary goal of this study is to compare the femorotibial mismatch angle of two groups of patients: patients undergoing posterior stabilized, fixed bearing TKR with conventional Attune® instrumentation (DePuy Johnson \& Johnson, Warsaw, Indiana), versus patient undergoing TKR with the TruMatch® (DePuy Johnson \& Johnson, Warsaw, Indiana) cutting guide.

Detailed description

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	TruMatch® patient specific cutting guide

Timeline

• Start date: 2013-06-01
• Primary completion: 2017-04-30
• Completion: 2017-04-30
• First posted: 2013-06-12
• Last updated: 2017-05-12

Locations

1 site across 1 country: Italy