Clinical trial NCT01876654: Evaluation of the TruMatch® System in Knee Prosthetic Surgery
Official title: Evaluation of the TruMatch® Personalized Solutions System in Knee Prosthetic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Total Knee Replacement
Patient specific instrumentation
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Femorotibial mismatch angle
timeFrame: 2 months after surgery
Secondary outcomes:
measure: Knee function
timeFrame: 2 months after surgery
Other outcomes:
measure: Operative time
timeFrame: During surgery
measure: Blood loss
timeFrame: 3-7 days after surgery
measure: Alignment
timeFrame: 2 months after surgery
Locations:
city: San Donato Milanese
country: Italy
facility: Unità Operativa Ortopedia II, Policlinico San Donato (Istituto di Ricovero e Cura a Carattere Scientifico)
state: MI
Study officials:
affiliation: University of Milan
name: Pietro S. Randelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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. doi: 10.1302/0301-620x.86b6.15456.
citation: 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.
citation: 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.
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.
citation: 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.