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Osteoarthritis, KneeNCT01876654

Evaluation of the TruMatch® System in Knee Prosthetic Surgery

A study testing TruMatch® patient specific cutting guide in people with Osteoarthritis, Knee, run by University of Milan at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
TruMatch® patient specific cutting guide
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteItaly
Study dates
Jun 2013to 30 Apr 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 40, <80
  • Indication for TKR
  • Surgical indication for Attune®, posterior stabilized, fixed bearing TKR
  • Patients signed written informed consent

Who cannot join

  • 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
Show all 10Show fewer
  • Informed consent not accepted
  • Serious comorbidity
  • Active infections
  • Pregnant or breastfeeding women

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    San Donato Milanese, MI, 20097

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
TruMatch® patient specific cutting guide
Keywords
Total Knee Replacement, Patient specific instrumentation
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TruMatch® patient specific cutting guideDevice

    Also called TruMatch® Personalized Solutions (DePuy).

Study groups in NCT01876654
Study groupRoleWhat they receive
TruMatch® patient specific cutting guideExperimentalIn patients randomized to experimental arm, TKR components will be implanted using TruMatch® patient specific cutting guides.
Receives: Device: TruMatch® patient specific cutting guide
Conventional cutting guideNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2 months after surgery

Secondary outcomes (1)

  1. Knee function

    For evaluation of knee function, patients will be asked to fill in the OKS questionnaire.

    Measured: 2 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completion30 Apr 2017
  4. Study completion30 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01876654
Sponsor's protocol ID
TruMatch02
Status last verified
May 2017
First submitted
10 Jun 2013
Last updated
12 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Fang DM, Ritter MA, Davis KE. Coronal alignment in total knee arthroplasty: just how important is it? J Arthroplasty. 2009 Sep;24(6 Suppl):39-43. doi: 10.1016/j.arth.2009.04.034. Epub 2009 Jun 24.

    PubMed 19553073

  • Longstaff LM, Sloan K, Stamp N, Scaddan M, Beaver R. Good alignment after total knee arthroplasty leads to faster rehabilitation and better function. J Arthroplasty. 2009 Jun;24(4):570-8. doi: 10.1016/j.arth.2008.03.002. Epub 2008 May 19.

    PubMed 18534396

  • Nunley RM, Ellison BS, Zhu J, Ruh EL, Howell SM, Barrack RL. Do patient-specific guides improve coronal alignment in total knee arthroplasty? Clin Orthop Relat Res. 2012 Mar;470(3):895-902. doi: 10.1007/s11999-011-2222-2. Epub 2011 Dec 20.

    PubMed 22183477

  • Chauhan SK, Clark GW, Lloyd S, Scott RG, Breidahl W, Sikorski JM. Computer-assisted total knee replacement. A controlled cadaver study using a multi-parameter quantitative CT assessment of alignment (the Perth CT Protocol). J Bone Joint Surg Br. 2004 Aug;86(6):818-23. doi: 10.1302/0301-620x.86b6.15456.

    PubMed 15330021

  • Bell SW, Young P, Drury C, Smith J, Anthony I, Jones B, Blyth M, McLean A. Component rotational alignment in unexplained painful primary total knee arthroplasty. Knee. 2014 Jan;21(1):272-7. doi: 10.1016/j.knee.2012.09.011. Epub 2012 Nov 7.

    PubMed 23140906

  • Rienmuller A, Guggi T, Gruber G, Preiss S, Drobny T. The effect of femoral component rotation on the five-year outcome of cemented mobile bearing total knee arthroplasty. Int Orthop. 2012 Oct;36(10):2067-72. doi: 10.1007/s00264-012-1628-0. Epub 2012 Aug 1.

    PubMed 22851124

  • Heyse TJ, Tibesku CO. Improved femoral component rotation in TKA using patient-specific instrumentation. Knee. 2014 Jan;21(1):268-71. doi: 10.1016/j.knee.2012.10.009. Epub 2012 Nov 8.

    PubMed 23140905

  • Randelli PS, Menon A, Pasqualotto S, Zanini B, Compagnoni R, Cucchi D. Patient-Specific Instrumentation Does Not Affect Rotational Alignment of the Femoral Component and Perioperative Blood Loss in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial. J Arthroplasty. 2019 Jul;34(7):1374-1381.e1. doi: 10.1016/j.arth.2019.03.018. Epub 2019 Mar 13.

    PubMed 30979672

Questions about this trial

What is this clinical trial studying?

A study testing TruMatch® patient specific cutting guide in people with Osteoarthritis, Knee, run by University of Milan at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Femorotibial mismatch angle (time frame: 2 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01876654, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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