An interventional study of TruMatch® patient specific cutting guide in Osteoarthritis, Knee, sponsored by University of Milan. Completed at 1 site in Italy. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-12.
Sponsored by University of Milan · Not applicable, Interventional, and Treatment
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.
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:
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 64 is close to the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →University of Milan is the lead sponsor of 182 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
In patients randomized to experimental arm, TKR components will be implanted using TruMatch® patient specific cutting guides.
Device: TruMatch® patient specific cutting guide
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.
Also known as: TruMatch® Personalized Solutions (DePuy).
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).
Time frame: 2 months after surgery
Knee function
For evaluation of knee function, patients will be asked to fill in the OKS questionnaire.
Time frame: 2 months after surgery
Operative time
Tourniquet application time will be recorded during surgery.
Time frame: During surgery
Blood loss
Intra- and post-operative blood loss will be measured and compared between the two treatment arms.
Time frame: 3-7 days after surgery
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.
Time frame: 2 months after surgery
Plan to share: No
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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