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OpenTrials
Completed

NCT Number: NCT01751334

Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty

The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

Reference of tibial AP axis for implanting tibial component in total knee arthroplasty have not been concluded. This study can suggest appropriate method for alingning the tibial component to accurate tibial AP axis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary osteoarthritis

Exclusion criteria

  • infection
  • inflammatory arthritis
  • reoperation
  • severe deformity

Treatment and study plan

Total knee arthroplasty

Device

Mobile Bearing Total knee Arthroplasty

Other names: Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USA

Primary outcomes

  1. Tibial anteroposterior axis relative to femoral anteroposterior axis

    Time frame: postoperative 2 weeks

    Tibial anteroposterior axis relative to femoral anteroposterior axis on Computed tomogram images

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2011
First posted
Dec 18, 2012
Registry last updated
Dec 18, 2012

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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