Evaluation of the TruMatch® System in Knee Prosthetic Surgery

May 10, 2017 updated by: Pietro Randelli, MD, University of Milan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • San Donato Milanese, MI, Italy, 20097
        • Unità Operativa Ortopedia II, Policlinico San Donato (Istituto di Ricovero e Cura a Carattere Scientifico)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TruMatch® patient specific cutting guide
In patients randomized to experimental arm, TKR components will be implanted using TruMatch® patient specific cutting guides.
Device: TruMatch® patient specific cutting guide
Other Names:
  • TruMatch® Personalized Solutions (DePuy).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Femorotibial mismatch angle
Time Frame: 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).
2 months after surgery

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: During surgery
Tourniquet application time will be recorded during surgery.
During surgery
Blood loss
Time Frame: 3-7 days after surgery
Intra- and post-operative blood loss will be measured and compared between the two treatment arms.
3-7 days after surgery
Alignment
Time Frame: 2 months after surgery
Coronal limb alignment, alignment in the coronal, sagittal and axial plane of the femoral component and alignment in the coronal and sagittal plane of the tibial component will be measured using a knee CT-scan, anteroposterior and laterolateral scanograms.
2 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Pietro S. Randelli, MD, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Actual)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TruMatch02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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