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

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ClinicalTrials.gov Identifier: NCT00865865
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : March 19, 2009
Sponsor:
Information provided by:
Singapore General Hospital

Brief Summary:
Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Procedure: Computer aided total knee arthroplasty Procedure: Conventional total knee arthroplasty Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
1
Conventional total knee arthroplasty
Procedure: Conventional total knee arthroplasty
Conventional method of total knee arthroplasty
Active Comparator: 2
Computer aided total knee arthroplasty
Procedure: Computer aided total knee arthroplasty
Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty
Other Name: Computer aided surgery



Primary Outcome Measures :
  1. Sagittal stability of knee [ Time Frame: 2 YEARS ]

Secondary Outcome Measures :
  1. Functional status of postoperative patients [ Time Frame: 2 YEARS ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT00865865


Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: SENG-JIN YEO, FRCS Singapore General Hospital

Responsible Party: DR SENG-JIN YEO, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00865865     History of Changes
Other Study ID Numbers: #48/2006
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 2009

Keywords provided by Singapore General Hospital:
Knee
Computer
Gap
Soft tissue
Balancing
Replacement
Arthroplasty

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