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
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 Names:
  • Computer aided surgery

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

Singapore General Hospital

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.

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