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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Device: Computer assisted navigation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Functional flexion axis of the knee; 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.	Device: Computer assisted navigation

Collaborators and Investigators

• Sponsor: Stryker Instruments
• Investigators: Principal Investigator: R S Oliver, M.D., Jordan Hospital

Publications and helpful links

General 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. doi: 10.1016/j.arth.2005.10.020.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2007
• Primary Completion (ACTUAL): June 1, 2007
• Study Completion (ACTUAL): June 1, 2007

Study Registration Dates

• First Submitted: December 6, 2006
• First Submitted That Met QC Criteria: December 7, 2006
• First Posted (ESTIMATE): December 8, 2006

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NAV06-01US