Evaluation of the TruMatch® System in Knee Prosthetic Surgery
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TruMatch® patient specific cutting guide
Sponsored by
![University of Milan](https://trials-media.s3.amazonaws.com/orgs/university-of-milan.jpeg)
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Total Knee Replacement, Patient specific instrumentation
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
Sites / Locations
- Unità Operativa Ortopedia II, Policlinico San Donato (Istituto di Ricovero e Cura a Carattere Scientifico)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TruMatch® patient specific cutting guide
Conventional cutting guide
Arm Description
In patients randomized to experimental arm, TKR components will be implanted using TruMatch® patient specific cutting guides.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Knee function
For evaluation of knee function, patients will be asked to fill in the OKS questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01876654
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Total Knee Replacement, Patient specific instrumentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TruMatch® patient specific cutting guide
Arm Type
Experimental
Arm Description
In patients randomized to experimental arm, TKR components will be implanted using TruMatch® patient specific cutting guides.
Arm Title
Conventional cutting guide
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
TruMatch® patient specific cutting guide
Other Intervention Name(s)
TruMatch® Personalized Solutions (DePuy).
Primary Outcome Measure Information:
Title
Femorotibial mismatch angle
Description
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
Secondary Outcome Measure Information:
Title
Knee function
Description
For evaluation of knee function, patients will be asked to fill in the OKS questionnaire.
Time Frame
2 months after surgery
Other Pre-specified Outcome Measures:
Title
Operative time
Description
Tourniquet application time will be recorded during surgery.
Time Frame
During surgery
Title
Blood loss
Description
Intra- and post-operative blood loss will be measured and compared between the two treatment arms.
Time Frame
3-7 days after surgery
Title
Alignment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pietro S. Randelli, MD
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unità Operativa Ortopedia II, Policlinico San Donato (Istituto di Ricovero e Cura a Carattere Scientifico)
City
San Donato Milanese
State/Province
MI
ZIP/Postal Code
20097
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19553073
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.
Results Reference
background
PubMed Identifier
18534396
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.
Results Reference
background
PubMed Identifier
22183477
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.
Results Reference
background
PubMed Identifier
15330021
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.
Results Reference
background
PubMed Identifier
23140906
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.
Results Reference
background
PubMed Identifier
22851124
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.
Results Reference
background
PubMed Identifier
23140905
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.
Results Reference
background
PubMed Identifier
30979672
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.
Results Reference
derived
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Evaluation of the TruMatch® System in Knee Prosthetic Surgery
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