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

Osteoarthritis of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449474
• Other study ID #: Si050/2554(EC2)
• Status: Completed
• Phase: N/A
• First received: October 6, 2011
• Last updated: February 21, 2013
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: February 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis of Knee
• Osteoarthritis, Knee

Intervention

Device:
• Patient matched instruments
The patients undergo TKA with using patient matched instruments
• Jig based instruments
The patients undergo TKA with using jig based instruments

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The alignment of mechanical axis after TKA		Within 1 month after operation	No
Secondary	The alignment of femoral and tibial components after TKA		Within 1 month after operation	No