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NCT00865865 Clinical Trial

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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00865865
Other study ID # #48/2006
Secondary ID
Status Completed
Phase N/A
First received March 17, 2009
Last updated March 18, 2009
Start date May 2006
Est. completion date December 2008

Study information
Verified date March 2009
Source Singapore General Hospital
Contact n/a
Is FDA regulated No
Health authority Singapore: Domain Specific Review Boards
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Computer aided total knee arthroplasty
Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty
• Conventional total knee arthroplasty
Conventional method of total knee arthroplasty

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Singapore General Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Sagittal stability of knee 2 YEARS No
Secondary Functional status of postoperative patients 2 YEARS No
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