Evaluation of the TruMatch® System in Knee Prosthetic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-04-30

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.

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TruMatch® patient specific cutting guide

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

Group Type EXPERIMENTAL

TruMatch® patient specific cutting guide

Intervention Type DEVICE

Conventional cutting guide

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TruMatch® patient specific cutting guide

Intervention Type DEVICE

Other Intervention Names

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TruMatch® Personalized Solutions (DePuy).

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No