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:
Information provided by (Responsible Party):
Young Hoo Kim, Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01520571
First received: January 19, 2012
Last updated: January 25, 2012
Last verified: January 2012
  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 Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Improvement in Knee Society Knee Score [ Time Frame: 10.5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   49 Years to 88 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 19, 2012
Last Updated: January 25, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ewha Womans University:
Computer Assistance
Total Knee Arthroplasty
conventional

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

ClinicalTrials.gov processed this record on August 28, 2014