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Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520571
First Posted: January 30, 2012
Last Update Posted: January 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Young Hoo Kim, Ewha Womans University
  Purpose
The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery due to aseptic loosening?

Condition Intervention Phase
Osteoarthritis Procedure: Non-Computer Assistance TKA Procedure: Computer Assistance TKA Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Young Hoo Kim, Ewha Womans University:

Primary Outcome Measures:
  • Improvement in Knee Society Knee Score [ Time Frame: 10.5 years ]
    change in knee score will be compared with initial score, until follow up of 10.5 years


Secondary Outcome Measures:
  • Improvement in the range of motion [ Time Frame: 10.5 years ]
    change in the range of motion of knee joint will be compared with the initial value, until follow up of 10.5 years.


Enrollment: 520
Study Start Date: January 2000
Study Completion Date: December 2011
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-Computer Assistance TKA
Non-Computer Assistance TKA
Procedure: Non-Computer Assistance TKA
Non-Computer Assistance Total Knee Arthroplasty
Other Name: Non-Computer Assistance Total Knee Arthroplasty
Experimental: Computer Assistance TKA
Computer Assistance TKA
Procedure: Computer Assistance TKA
Computer Assistance Total Knee Arthroplasty
Other Name: Computer Assistance Total Knee Arthroplasty

Detailed Description:
Computer-assisted total knee arthroplasty (TKA) is reported to improve the overall accuracy of positioning of the femoral and tibia components. However, an acceptable target for alignment remains a matter for debate. A mechanical axis within 3° of neutral axis has been used as the primary outcome measure in many clinical trials comparing computer-assisted- and conventional TKA. However, the evidence supporting this arbitrary value is unreliable because previous reports are limited by their small sample size, inadequate radiographs, short follow-up and lack of clarity when defining a margin of accuracy.
  Eligibility

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Ages Eligible for Study:   49 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.

Exclusion Criteria:

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery
  Contacts and Locations
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): NCT01520571


Locations
Korea, Republic of
Ewha Womans University Mokdong Hosptial
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Ewha Womans University
Investigators
Study Director: Young-Hoo Kim, MD Ewha Womans University School of Medicine
  More Information

Responsible Party: Young Hoo Kim, Professor and Director, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01520571     History of Changes
Other Study ID Numbers: Computer Assistance TKA
First Submitted: January 19, 2012
First Posted: January 30, 2012
Last Update Posted: January 30, 2012
Last Verified: January 2012

Keywords provided by Young Hoo Kim, Ewha Womans University:
Computer Assistance
Total Knee Arthroplasty
conventional

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