Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2011
CompletedFebruary 22, 2013
February 1, 2013
6 months
October 6, 2011
February 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
The alignment of mechanical axis after TKA
Within 1 month after operation
Secondary Outcomes (1)
The alignment of femoral and tibial components after TKA
Within 1 month after operation
Study Arms (2)
Group 1
EXPERIMENTALPatient matched instruments
Group 2
EXPERIMENTALJig based instruments
Interventions
The patients undergo TKA with using patient matched instruments
The patients undergo TKA with using jig based instruments
Eligibility Criteria
You may qualify if:
- Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 23450020DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keerati Charoencholvanich, MD
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2011
First Posted
October 10, 2011
Study Start
April 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
February 22, 2013
Record last verified: 2013-02