Evaluation of the TruMatch® System in Knee Prosthetic Surgery

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Device: TruMatch® patient specific cutting guide

• Registration Number: NCT01876654
• Lead Sponsor: University of Milan

Brief 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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-12
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TruMatch® patient specific cutting guide	TruMatch® patient specific cutting guide	In patients randomized to experimental arm, TKR components will be implanted using TruMatch® patient specific cutting guides.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Knee function	2 months after surgery	For evaluation of knee function, patients will be asked to fill in the OKS questionnaire.

Trial Locations

Locations (1)

Unità Operativa Ortopedia II, Policlinico San Donato (Istituto di Ricovero e Cura a Carattere Scientifico); 🇮🇹 San Donato Milanese, MI, Italy