Evaluation of the TruMatch® System in Knee Prosthetic Surgery

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876654
• Other study ID #: TruMatch02
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: May 10, 2017
• Start date: June 2013
• Est. completion date: April 30, 2017

Study information

• Verified date: May 2017
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• TruMatch® patient specific cutting guide

Locations

Country	Name	City	State
Italy	Unità Operativa Ortopedia II, Policlinico San Donato (Istituto di Ricovero e Cura a Carattere Scientifico)	San Donato Milanese	MI

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: Clin Orthop Relat Res. 2012 Apr;470(4):1242. — View Citation

Rienmüller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operative time	Tourniquet application time will be recorded during surgery.	During surgery
Other	Blood loss	Intra- and post-operative blood loss will be measured and compared between the two treatment arms.	3-7 days after surgery
Other	Alignment	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
Primary	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	Knee function	For evaluation of knee function, patients will be asked to fill in the OKS questionnaire.	2 months after surgery