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

NCT ID: NCT01449474

Last Updated: 2013-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-10-31

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.

Conditions

Osteoarthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Patient matched instruments

Group Type: EXPERIMENTAL

Patient matched instruments

Intervention Type: DEVICE

The patients undergo TKA with using patient matched instruments

Group 2

Jig based instruments

Group Type: EXPERIMENTAL

Jig based instruments

Intervention Type: DEVICE

The patients undergo TKA with using jig based instruments

Interventions

Patient matched instruments

The patients undergo TKA with using patient matched instruments

Intervention Type: DEVICE

Jig based instruments

The patients undergo TKA with using jig based instruments

Intervention Type: DEVICE

Other Intervention Names

The Zimmer Patient Specific Instruments System; Zimmer Nexgen LPS MIS system

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keerati Charoencholvanich, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

References

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.

Reference Type: DERIVED

PMID: 23450020 (View on PubMed)

Other Identifiers

Si050/2554(EC2)

Identifier Type: -

Identifier Source: org_study_id