Skip to main content
Clinical Trials/NCT01449474
NCT01449474
Completed
Not Applicable

Accuracy of MRI-based Patients Matched Instruments and Jig-based Instruments in Total Knee Arthroplasty

Mahidol University0 sites80 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis of Knee
Sponsor
Mahidol University
Enrollment
80
Primary Endpoint
The alignment of mechanical axis after TKA
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
October 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The alignment of mechanical axis after TKA

Time Frame: Within 1 month after operation

Secondary Outcomes

  • The alignment of femoral and tibial components after TKA(Within 1 month after operation)

Similar Trials