NCT00865865

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

2.6 years

First QC Date

March 17, 2009

Last Update Submit

March 18, 2009

Conditions

Osteoarthritis of the Knee

Keywords

KneeComputerGapSoft tissueBalancingReplacementArthroplasty

Outcome Measures

Primary Outcomes (1)

  • Sagittal stability of knee

    2 YEARS

Secondary Outcomes (1)

  • Functional status of postoperative patients

    2 YEARS

Study Arms (2)

1

OTHER

Conventional total knee arthroplasty

Procedure: Conventional total knee arthroplasty

2

ACTIVE COMPARATOR

Computer aided total knee arthroplasty

Procedure: Computer aided total knee arthroplasty

Interventions

Computer aided total knee arthroplastyPROCEDURE

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

Also known as: Computer aided surgery
2
Conventional total knee arthroplastyPROCEDURE

Conventional method of total knee arthroplasty

1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary osteoarthritis of the knee

You may not qualify if:

  • rheumatoid arthritis, previous knee surgery, infection and those who could not be treated with unconstrained cruciate retaining TKA and a short stem tibial implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeCapillary Malformation-Arteriovenous Malformation

Interventions

Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • SENG-JIN YEO, FRCS

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 19, 2009

Study Start

May 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 19, 2009

Record last verified: 2009-03