Back to resultsFully Disposable Patient-Specific Instrumentation (MyKnee)
Primary Purpose
Osteoarthritis,Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GMK Medacta Total Knee arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis,Knee
Eligibility Criteria
Inclusion Criteria:
- patients aged between 18 and 85 years
- able to understand information
- affiliated to social security
Exclusion Criteria:
- active or suspected sepsis
- tumor around the knee
- previous partial or total knee replacement
- extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
- social situation that could impair follow-up
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
CI
PSCG
PSCG-D
Arm Description
TKA using conventional instrumentation (CI)
TKA performed using Patient specific cutting guides (PSCG)
TKA performed using fully disposable Patient specific cutting guides (PSCG-D)
Outcomes
Primary Outcome Measures
HKA angle
Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the Hip-Knee-Ankle (HKA) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.
Secondary Outcome Measures
% outliers
% of patients with an HKA angle outside 180°+/- 3°
Knee Society Score
Validated pain and function score following TKA
Oxford Knee Score
Patients self assessment of knee function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02966613
Brief Title
Fully Disposable Patient-Specific Instrumentation
Acronym
MyKnee
Official Title
Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cochin Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.
Detailed Description
The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis,Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CI
Arm Type
Active Comparator
Arm Description
TKA using conventional instrumentation (CI)
Arm Title
PSCG
Arm Type
Experimental
Arm Description
TKA performed using Patient specific cutting guides (PSCG)
Arm Title
PSCG-D
Arm Type
Experimental
Arm Description
TKA performed using fully disposable Patient specific cutting guides (PSCG-D)
Intervention Type
Device
Intervention Name(s)
GMK Medacta Total Knee arthroplasty
Intervention Description
Total Knee arthroplasty
Primary Outcome Measure Information:
Title
HKA angle
Description
Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the Hip-Knee-Ankle (HKA) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
% outliers
Description
% of patients with an HKA angle outside 180°+/- 3°
Time Frame
3 months
Title
Knee Society Score
Description
Validated pain and function score following TKA
Time Frame
3 months
Title
Oxford Knee Score
Description
Patients self assessment of knee function
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients aged between 18 and 85 years
able to understand information
affiliated to social security
Exclusion Criteria:
active or suspected sepsis
tumor around the knee
previous partial or total knee replacement
extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
social situation that could impair follow-up
12. IPD Sharing Statement
Citations:
PubMed Identifier
29576488
Citation
Abane L, Zaoui A, Anract P, Lefevre N, Herman S, Hamadouche M. Can a Single-Use and Patient-Specific Instrumentation Be Reliably Used in Primary Total Knee Arthroplasty? A Multicenter Controlled Study. J Arthroplasty. 2018 Jul;33(7):2111-2118. doi: 10.1016/j.arth.2018.02.038. Epub 2018 Feb 17.
Results Reference
derived
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Fully Disposable Patient-Specific Instrumentation
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