Evaluation of the TruMatch® System in Knee Prosthetic Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: TruMatch® patient specific cutting guide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TruMatch® patient specific cutting guide<br>In patients randomized to experimental arm, TKR components will be implanted using TruMatch® patient specific cutting guides. | Device: TruMatch® patient specific cutting guide<br> <br> * Other names: TruMatch® Personalized Solutions (DePuy).;|
| No Intervention: Conventional cutting guide<br>In patients randomized to control arm, TKR components will be implanted using Attune® instrumentation (femoral intra-medullary guide, tibial extra-medullary guide), without TruMatch® patient specific cutting guides. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femorotibial mismatch angle | Angle between the posterior femoral condylar plane and the plane passing trough the posterior end of the tibial keel (measured on axial CT-scan). | 2 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee function | For evaluation of knee function, patients will be asked to fill in the OKS questionnaire. | 2 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Patient specific instrumentation