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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01449474
First received: October 6, 2011
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Osteoarthritis of Knee
Device: Patient matched instruments
Device: Jig based instruments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Accuracy of MRI-based Patients Matched Instruments and Jig-based Instruments in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • The alignment of mechanical axis after TKA [ Time Frame: Within 1 month after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The alignment of femoral and tibial components after TKA [ Time Frame: Within 1 month after operation ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Patient matched instruments
Device: Patient matched instruments
The patients undergo TKA with using patient matched instruments
Other Name: The Zimmer Patient Specific Instruments System
Experimental: Group 2
Jig based instruments
Device: Jig based instruments
The patients undergo TKA with using jig based instruments
Other Name: Zimmer Nexgen LPS MIS system

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01449474

Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Keerati Charoencholvanich, MD Mahidol University
  More Information

No publications provided by Mahidol University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01449474     History of Changes
Other Study ID Numbers: Si050/2554(EC2)
Study First Received: October 6, 2011
Last Updated: February 21, 2013
Health Authority: Thailand: Ethical Committee
United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014