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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01751334
First received: December 13, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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 Intervention Phase
Osteoarthritis
 Device: total knee arthroplasty
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Tibial anteroposterior axis relative to femoral anteroposterior axis [ Time Frame: postoperative 2 weeks ] [ Designated as safety issue: No ]
    Tibial anteroposterior axis relative to femoral anteroposterior axis on Computed tomogram images


Enrollment: 80
Study Start Date: September 2005
Study Completion Date: August 2011
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary osteoarthritis

Exclusion Criteria:

  • infection
  • inflammatory arthritis
  • reoperation
  • severe deformity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01751334     History of Changes
Other Study ID Numbers: SNUHOSKNEE01-RPFLPSF
Study First Received: December 13, 2012
Last Updated: December 13, 2012
Health Authority: South Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013