Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)

Not Applicable

Completed

• Conditions: Osteoarthritis of Knee
• Interventions: Device: Patient matched instruments; Device: Jig based instruments

• Registration Number: NCT01449474
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Patient matched instruments	Patient matched instruments
Group 2	Jig based instruments	Jig based instruments

Primary Outcome Measures

Name	Time	Method
The alignment of mechanical axis after TKA	Within 1 month after operation

Secondary Outcome Measures

Name	Time	Method
The alignment of femoral and tibial components after TKA	Within 1 month after operation