Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty
March 18, 2009 updated by: Singapore General Hospital
Computer Aided Gap Balancing Improves Sagittal Stability and Outcomes for Cruciate-Retaining Total Knee Arthroplasty- 2-Year Results of a Prospective Randomised Trial
Computer Aided Surgery in total knee arthroplasty improves knee stability and functional outcomes more than conventional total knee arthroplasty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
140
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1
Conventional total knee arthroplasty
|
Conventional method of total knee arthroplasty
|
|
Active Comparator: 2
Computer aided total knee arthroplasty
|
Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sagittal stability of knee
Time Frame: 2 YEARS
|
2 YEARS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functional status of postoperative patients
Time Frame: 2 YEARS
|
2 YEARS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: SENG-JIN YEO, FRCS, Singapore General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
March 17, 2009
First Submitted That Met QC Criteria
March 18, 2009
First Posted (Estimate)
March 19, 2009
Study Record Updates
Last Update Posted (Estimate)
March 19, 2009
Last Update Submitted That Met QC Criteria
March 18, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #48/2006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.