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

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ClinicalTrials.gov Identifier: NCT01751334
Recruitment Status : Completed
First Posted : December 18, 2012
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: total knee arthroplasty Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty
Study Start Date : September 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mobile Bearing
Mobile bearing total knee arthroplasty
Device: total knee arthroplasty
Mobile Bearing Total knee Arthroplasty
Other Name: Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USA
Active Comparator: Fixed Bearing
Fixed Bearing total knee arthroplasty
Device: total knee arthroplasty
Fixed Total Knee Arthroplasty
Other Name: Nexgen® Legacy® Knee LPS-Flex, Zimmer, Warsaw, IN, USA



Primary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary osteoarthritis

Exclusion Criteria:

  • infection
  • inflammatory arthritis
  • reoperation
  • severe deformity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751334


Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sahnghoon Lee, M.D., Ph.D.
Study Chair: Myung Chul Lee, M.D., Ph.D.

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01751334     History of Changes
Other Study ID Numbers: SNUHOSKNEE01-RPFLPSF
First Posted: December 18, 2012    Key Record Dates
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Seoul National University Hospital:
Arthroplasty
Replacement
Knee
Rotational Alignment

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