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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Non-Computer Assistance TKA
Computer Assistance TKA
Sponsored by
Ewha Womans University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Computer Assistance, Total Knee Arthroplasty, conventional

Eligibility Criteria

49 Years - 88 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ewha Womans University Mokdong Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-Computer Assistance TKA

Computer Assistance TKA

Arm Description

Non-Computer Assistance TKA

Computer Assistance TKA

Outcomes

Primary Outcome Measures

Improvement in Knee Society Knee Score
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
change in the range of motion of knee joint will be compared with the initial value, until follow up of 10.5 years.

Full Information

First Posted
January 19, 2012
Last Updated
January 25, 2012
Sponsor
Ewha Womans University
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1. Study Identification

Unique Protocol Identification Number
NCT01520571
Brief Title
Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Computer Assistance, Total Knee Arthroplasty, conventional

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Computer Assistance TKA
Arm Type
Active Comparator
Arm Description
Non-Computer Assistance TKA
Arm Title
Computer Assistance TKA
Arm Type
Experimental
Arm Description
Computer Assistance TKA
Intervention Type
Procedure
Intervention Name(s)
Non-Computer Assistance TKA
Other Intervention Name(s)
Non-Computer Assistance Total Knee Arthroplasty
Intervention Description
Non-Computer Assistance Total Knee Arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Computer Assistance TKA
Other Intervention Name(s)
Computer Assistance Total Knee Arthroplasty
Intervention Description
Computer Assistance Total Knee Arthroplasty
Primary Outcome Measure Information:
Title
Improvement in Knee Society Knee Score
Description
change in knee score will be compared with initial score, until follow up of 10.5 years
Time Frame
10.5 years
Secondary Outcome Measure Information:
Title
Improvement in the range of motion
Description
change in the range of motion of knee joint will be compared with the initial value, until follow up of 10.5 years.
Time Frame
10.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoo Kim, MD
Organizational Affiliation
Ewha Womans University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ewha Womans University Mokdong Hosptial
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of

12. IPD Sharing Statement

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

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