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Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computer aided total knee arthroplasty
Conventional total knee arthroplasty
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Knee, Computer, Gap, Soft tissue, Balancing, Replacement, Arthroplasty

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • primary osteoarthritis of the knee

Exclusion Criteria:

  • rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining TKA and a short stem tibial implant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Conventional total knee arthroplasty

    Computer aided total knee arthroplasty

    Outcomes

    Primary Outcome Measures

    Sagittal stability of knee

    Secondary Outcome Measures

    Functional status of postoperative patients

    Full Information

    First Posted
    March 17, 2009
    Last Updated
    March 18, 2009
    Sponsor
    Singapore General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00865865
    Brief Title
    Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty
    Official Title
    Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty- 2-Year Results of a Prospective Randomised Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Singapore General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.
    Detailed Description
    The success of total knee arthroplasty depends on restoration of limb alignment, precise implant positioning and optimal gap balancing. The advent of computer aided surgery (CAS) has improved limb alignment and implant positioning. The objective of this study was to evaluate the functional outcome of computer aided soft tissue gap balancing in total knee arthroplasty.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis of the Knee
    Keywords
    Knee, Computer, Gap, Soft tissue, Balancing, Replacement, Arthroplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Other
    Arm Description
    Conventional total knee arthroplasty
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Computer aided total knee arthroplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Computer aided total knee arthroplasty
    Other Intervention Name(s)
    Computer aided surgery
    Intervention Description
    Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional total knee arthroplasty
    Intervention Description
    Conventional method of total knee arthroplasty
    Primary Outcome Measure Information:
    Title
    Sagittal stability of knee
    Time Frame
    2 YEARS
    Secondary Outcome Measure Information:
    Title
    Functional status of postoperative patients
    Time Frame
    2 YEARS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: primary osteoarthritis of the knee Exclusion Criteria: rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining TKA and a short stem tibial implant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SENG-JIN YEO, FRCS
    Organizational Affiliation
    Singapore General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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