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OpenTrials
Completed

NCT Number: NCT00862316

Oxford Unicompartmental Knee Arthroplasty With and Without 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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxford Unicompartmental Knee

Device

Knee Arthroplasty

Primary outcomes

  1. Operative record

    Time frame: Immediately Post-Op

  2. Visual Analogue for pain, activity, and patient satisfaction (VAS)

    Time frame: 1 year

  3. American Knee Society Score (AKSS)

    Time frame: 1 year

Secondary outcomes

  1. Oxford Knee 12

    Time frame: 1 year

  2. Western Ontario MacMaster(WOMAC)

    Time frame: 1 year

  3. SF 12

    Time frame: 1 year

  4. Gait Belt Analysis

    Time frame: 1 year

  5. Radiographic Output

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Collaborators

  • Dartmouth General Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 16, 2009
Registry last updated
Jun 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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