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

NCT ID: NCT00865865

Last Updated: 2009-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Conventional total knee arthroplasty

Group Type OTHER

Conventional total knee arthroplasty

Intervention Type PROCEDURE

Conventional method of total knee arthroplasty

2

Computer aided total knee arthroplasty

Group Type ACTIVE_COMPARATOR

Computer aided total knee arthroplasty

Intervention Type PROCEDURE

Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty

Interventions

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Computer aided total knee arthroplasty

Use of computer aided surgery to balance soft tissue tension in total knee arthroplasty

Intervention Type PROCEDURE

Conventional total knee arthroplasty

Conventional method of total knee arthroplasty

Intervention Type PROCEDURE

Other Intervention Names

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Computer aided surgery

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Singapore General Hospital

Principal Investigators

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SENG-JIN YEO, FRCS

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Other Identifiers

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#48/2006

Identifier Type: -

Identifier Source: org_study_id

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