Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

June 15, 2017 updated by: Zimmer Biomet

Outcome Analysis of the Oxford Unicompartmental Knee Arthroplasty With and Without the Assistance of a Computer Navigational Unit

The purpose of this study is to determine whether a computer navigational unit can improve operating time and consistency during Knee arthroplasty when compared to knee arthroplasty without a computer navigational unit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The ability to use a computerized navigational unit during knee arthroplasty can be a major benefit to surgeons that perform a small amount of knee arthroplasties. Navigational assistance can decrease surgery and anesthesia time as well as decreasing variation in posterior tibial slope and improved range of motion.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada
        • Dartmouth General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for the Oxford Knee

  • symptomatic unicompartmental knee arthritis major surgery
  • failed non operative treatment modalities
  • willing and able to give informed consent
  • skeletal maturity

Exclusion criteria for the Oxford Knee

  • medical conditions that preclude general or spinal anesthetic
  • ipsilateral knee avascular necrosis
  • severe osteoporosis or osteopenia
  • neuromuscular impairment
  • ipsilateral knee infection

Patient day surgery criteria

  • medically stable: an ASA category of 1 or 2
  • close proximity to the hospital surgery performed for at least 36 hours
  • good support system in place- someone able to stay with the patient for at least 36 hours immediately post-op.
  • hemovac to be removed prior to discharge
  • access to VON or other home care hospital approved services
  • pain buster for pain control for 24 to 36 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Computer Navigational Unit Assistance
Oxford Unicompartmental Knee arthroplasty will be performed with the assistance of a computer navigational unit.
Device: Oxford Unicompartmental Knee
Knee Arthroplasty
ACTIVE_COMPARATOR: Non- Computer Navigational Unit Assisted
Oxford Unicompartmental Knee arthroplasty will be performed traditionally (without the assistance of a computer navigational unit).
Device: Oxford Unicompartmental Knee
Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Operative record
Time Frame: Immediately Post-Op
Immediately Post-Op
Visual Analogue for pain, activity, and patient satisfaction (VAS)
Time Frame: 1 year
1 year
American Knee Society Score (AKSS)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Oxford Knee 12
Time Frame: 1 year
1 year
Western Ontario MacMaster(WOMAC)
Time Frame: 1 year
1 year
SF 12
Time Frame: 1 year
1 year
Gait Belt Analysis
Time Frame: 1 year
1 year
Radiographic Output
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

Dartmouth General Hospital

Investigators

  • Principal Investigator: Vikram Venugopal, Dr., Dartmouth General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (ESTIMATE)

March 16, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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