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

Mahidol University

Status: Completed

Conditions: Osteoarthritis of Knee

Treatments: Device: Jig based instruments; Device: Patient matched instruments

Study type: Interventional

Funder types: Other

Identifiers

NCT01449474

Si050/2554(EC2)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Group 1

Experimental group

Description:

Patient matched instruments

Treatment:

Device: Patient matched instruments

Group 2

Experimental group

Description:

Jig based instruments

Treatment:

Device: Jig based instruments