Back to resultsAccuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)
Primary Purpose
Osteoarthritis of Knee
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient matched instruments
Jig based instruments
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Knee
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty
Exclusion Criteria:
- Previous complex surgery of the affected knee
- Metalic implant in the affected lower limb
- Patients who unable or contraindicated to perform MRI
- Extra-articular deformities of the affected lower limb
- Extensive bone loss of distal femur or/and proximal tibia
- More than 30 degrees of knee flexion contracture
- Unable to perform TKA within 12 weeks after MRI
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Patient matched instruments
Jig based instruments
Outcomes
Primary Outcome Measures
The alignment of mechanical axis after TKA
Secondary Outcome Measures
The alignment of femoral and tibial components after TKA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01449474
Brief Title
Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)
Official Title
Accuracy of MRI-based Patients Matched Instruments and Jig-based Instruments in Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Total knee arthroplasty (TKA) is the common and effective procedure for treatment of end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important factors which effects on survival of prosthesis. High percentage of misalignment has been reported in conventional technique with using the jig based instruments. Several methods and devices were established to solve this problem. Customized or patient matched instruments were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With using special software to calculate the alignment axis, it was thought that accurate alignment can be achieved by using this instruments. Therefore, the study aimed to compare the accuracy of MRI based patient matched instruments and jig based instruments in TKA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Patient matched instruments
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Jig based instruments
Intervention Type
Device
Intervention Name(s)
Patient matched instruments
Other Intervention Name(s)
The Zimmer Patient Specific Instruments System
Intervention Description
The patients undergo TKA with using patient matched instruments
Intervention Type
Device
Intervention Name(s)
Jig based instruments
Other Intervention Name(s)
Zimmer Nexgen LPS MIS system
Intervention Description
The patients undergo TKA with using jig based instruments
Primary Outcome Measure Information:
Title
The alignment of mechanical axis after TKA
Time Frame
Within 1 month after operation
Secondary Outcome Measure Information:
Title
The alignment of femoral and tibial components after TKA
Time Frame
Within 1 month after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty
Exclusion Criteria:
Previous complex surgery of the affected knee
Metalic implant in the affected lower limb
Patients who unable or contraindicated to perform MRI
Extra-articular deformities of the affected lower limb
Extensive bone loss of distal femur or/and proximal tibia
More than 30 degrees of knee flexion contracture
Unable to perform TKA within 12 weeks after MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keerati Charoencholvanich, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23450020
Citation
Chareancholvanich K, Narkbunnam R, Pornrattanamaneewong C. A prospective randomised controlled study of patient-specific cutting guides compared with conventional instrumentation in total knee replacement. Bone Joint J. 2013 Mar;95-B(3):354-9. doi: 10.1302/0301-620X.95B3.29903.
Results Reference
derived
Learn more about this trial
Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)
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