NCT00279838

Brief Summary

The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty (TKA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

2.8 years

First QC Date

January 18, 2006

Last Update Submit

March 22, 2011

Conditions

Total Knee ArthroplastyOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation

Secondary Outcomes (3)

  • To compare the frontal alignment of the femoral and tibial components from full length standing radiographs

  • To compare sagittal alignment of the femoral and tibial components from lateral radiographs

  • To compare the rotation of the femoral and tibial components from CT Scan.

Interventions

Computer Assisted Navigation Knee ReplacementPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Study participants must: 1. Be over 18 years of age. 2. Require a TKA and is considered by the investigator to be a suitable candidate for the specific knee prosthesis identified in protocol. 3. The subject has given consent to the transfer of his/her information to the sponsor.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Mary I. O'Connor, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2006

First Posted

January 20, 2006

Study Start

June 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations

US(1)