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Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862316
Recruitment Status : Completed
First Posted : March 16, 2009
Last Update Posted : June 16, 2017
Sponsor:
Collaborator:
Dartmouth General Hospital
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Arthritis Device: Oxford Unicompartmental Knee Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome Analysis of the Oxford Unicompartmental Knee Arthroplasty With and Without the Assistance of a Computer Navigational Unit
Study Start Date : May 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862316


Locations
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Canada, Nova Scotia
Dartmouth General Hospital
Dartmouth, Nova Scotia, Canada
Sponsors and Collaborators
Zimmer Biomet
Dartmouth General Hospital
Investigators
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Principal Investigator: Vikram Venugopal, Dr. Dartmouth General Hospital
Publications:
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00862316    
Other Study ID Numbers: CA4
First Posted: March 16, 2009    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Keywords provided by Zimmer Biomet:
Eligible for Unicompartmental Knee Arthritis
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases