Osteoarthritis, Knee
Conditions
Keywords
Total Knee Replacement, Patient specific instrumentation
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.
Interventions
DEVICETruMatch® patient specific cutting guide
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Femorotibial mismatch angle | 2 months after surgery | Angle between the posterior femoral condylar plane and the plane passing trough the posterior end of the tibial keel (measured on axial CT-scan). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee function | 2 months after surgery | For evaluation of knee function, patients will be asked to fill in the OKS questionnaire. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative time | During surgery | Tourniquet application time will be recorded during surgery. |
| Blood loss | 3-7 days after surgery | Intra- and post-operative blood loss will be measured and compared between the two treatment arms. |
| Alignment | 2 months after surgery | 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. |
Countries
Italy
Outcome results
None listed