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Completed

NCT Number: NCT01449474

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

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.

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Key information

Conditions

Osteoarthritis of Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient matched instruments

Device

The patients undergo TKA with using patient matched instruments

Other names: The Zimmer Patient Specific Instruments System

Jig based instruments

Device

The patients undergo TKA with using jig based instruments

Other names: Zimmer Nexgen LPS MIS system

Primary outcomes

  1. The alignment of mechanical axis after TKA

    Time frame: Within 1 month after operation

Secondary outcomes

  1. The alignment of femoral and tibial components after TKA

    Time frame: Within 1 month after operation

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 10, 2011
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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