Evaluation of the TruMatch® System in Knee Prosthetic Surgery

University of Milan

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: TruMatch® patient specific cutting guide

Study type: Interventional

Funder types: Other

Identifiers

NCT01876654

TruMatch02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64 participants in 2 patient groups

TruMatch® patient specific cutting guide

Experimental group

Description:

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

Treatment:

Device: TruMatch® patient specific cutting guide

Conventional cutting guide

No Intervention group

Description:

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.