CT Assessment of Minimally Invasive Surgery and Computer Assisted Navigation in Total Knee Arthroplasty

This study is not yet open for participant recruitment.

Verified by Stryker Instruments, December 2006

First Received: December 6, 2006 Last Updated: December 7, 2006 History of Changes

Sponsored by:	Stryker Instruments
Information provided by:	Stryker Instruments
ClinicalTrials.gov Identifier:	NCT00409266

Purpose

The functional flexion axis of the knee can be established by computer-assisted intra-operative data, through range of motion techniques, not specific landmarks such as epicondyles.

Condition	Intervention	Phase
Total Knee Replacement	Device: Computer assisted navigation	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Males and Females over the age of 18 and equal to or less than the age of 60
Patients scheduled for elective Total knee arthroplasty surgery
Patients who have signed informed consent and HIPAA Authorization
Able to speak and understand English

Exclusion Criteria:

Patients presenting with evidence of recent trauma, active infection, chronic pain syndrome of the spine, dementia or have been diagnosed with Alzheimer’s disease
Pregnant women
Patients that will not sign the informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409266

Contacts

Contact: R Scott Oliver, M.D.

781-934-2400

rsolivermd@hotmail.com

Locations

United States, Massachusetts
Jordan Hospital
Plymouth, Massachusetts, United States, 02360

Sponsors and Collaborators

Stryker Instruments

Investigators

Principal Investigator:

R S Oliver, M.D.

Jordan Hospital

More Information

Publications:

Stoeckl B, Nogler M, Krismer M, Beimel C, de la Barrera JL, Kessler O. Reliability of the transepicondylar axis as an anatomical landmark in total knee arthroplasty. J Arthroplasty. 2006 Sep;21(6):878-82.

Study ID Numbers:	NAV06-01US
Study First Received:	December 6, 2006
Last Updated:	December 7, 2006
ClinicalTrials.gov Identifier:	NCT00409266 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 01, 2009