NCT01876654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

3.9 years

First QC Date

June 10, 2013

Last Update Submit

May 10, 2017

Conditions

Osteoarthritis, Knee

Keywords

Total Knee ReplacementPatient specific instrumentation

Outcome Measures

Primary Outcomes (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).

    2 months after surgery

Secondary Outcomes (1)

  • Knee function

    2 months after surgery

Other Outcomes (3)

  • Operative time

    During surgery

  • Blood loss

    3-7 days after surgery

  • Alignment

    2 months after surgery

Study Arms (2)

TruMatch® patient specific cutting guide

EXPERIMENTAL

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

Device: TruMatch® patient specific cutting guide

Conventional cutting guide

NO INTERVENTION

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.

Interventions

TruMatch® patient specific cutting guideDEVICE
Also known as: TruMatch® Personalized Solutions (DePuy).
TruMatch® patient specific cutting guide

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Donato Milanese, MI, 20097, Italy

Location

Related Publications (8)

  • 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.

    PMID: 19553073BACKGROUND

  • 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.

    PMID: 18534396BACKGROUND

  • 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.

    PMID: 22183477BACKGROUND

  • 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.

    PMID: 15330021BACKGROUND

  • 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.

    PMID: 23140906BACKGROUND

  • 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.

    PMID: 22851124BACKGROUND

  • 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.

    PMID: 23140905BACKGROUND

  • 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.

    PMID: 30979672DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Pietro S. Randelli, MD

    University of Milan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

June 1, 2013

Primary Completion

April 30, 2017

Study Completion

April 30, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)