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Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

Primary Purpose

Knee Arthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Oxford Unicompartmental Knee
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthritis focused on measuring Eligible for Unicompartmental Knee Arthritis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Computer Navigational Unit Assistance

Non- Computer Navigational Unit Assisted

Arm Description

Oxford Unicompartmental Knee arthroplasty will be performed with the assistance of a computer navigational unit.

Oxford Unicompartmental Knee arthroplasty will be performed traditionally (without the assistance of a computer navigational unit).

Outcomes

Primary Outcome Measures

Operative record
Visual Analogue for pain, activity, and patient satisfaction (VAS)
American Knee Society Score (AKSS)

Secondary Outcome Measures

Oxford Knee 12
Western Ontario MacMaster(WOMAC)
SF 12
Gait Belt Analysis
Radiographic Output

Full Information

First Posted
February 3, 2009
Last Updated
June 15, 2017
Sponsor
Zimmer Biomet
Collaborators
Dartmouth General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00862316
Brief Title
Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit
Official Title
Outcome Analysis of the Oxford Unicompartmental Knee Arthroplasty With and Without the Assistance of a Computer Navigational Unit
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
Collaborators
Dartmouth General Hospital

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis
Keywords
Eligible for Unicompartmental Knee Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer Navigational Unit Assistance
Arm Type
Experimental
Arm Description
Oxford Unicompartmental Knee arthroplasty will be performed with the assistance of a computer navigational unit.
Arm Title
Non- Computer Navigational Unit Assisted
Arm Type
Active Comparator
Arm Description
Oxford Unicompartmental Knee arthroplasty will be performed traditionally (without the assistance of a computer navigational unit).
Intervention Type
Device
Intervention Name(s)
Oxford Unicompartmental Knee
Intervention Description
Knee Arthroplasty
Primary Outcome Measure Information:
Title
Operative record
Time Frame
Immediately Post-Op
Title
Visual Analogue for pain, activity, and patient satisfaction (VAS)
Time Frame
1 year
Title
American Knee Society Score (AKSS)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Oxford Knee 12
Time Frame
1 year
Title
Western Ontario MacMaster(WOMAC)
Time Frame
1 year
Title
SF 12
Time Frame
1 year
Title
Gait Belt Analysis
Time Frame
1 year
Title
Radiographic Output
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vikram Venugopal, Dr.
Organizational Affiliation
Dartmouth General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth General Hospital
City
Dartmouth
State/Province
Nova Scotia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11284563
Citation
Svard UC, Price AJ. Oxford medial unicompartmental knee arthroplasty. A survival analysis of an independent series. J Bone Joint Surg Br. 2001 Mar;83(2):191-4. doi: 10.1302/0301-620x.83b2.10966.
Results Reference
background
PubMed Identifier
9853489
Citation
Murray DW, Goodfellow JW, O'Connor JJ. The Oxford medial unicompartmental arthroplasty: a ten-year survival study. J Bone Joint Surg Br. 1998 Nov;80(6):983-9. doi: 10.1302/0301-620x.80b6.8177.
Results Reference
background
PubMed Identifier
11740750
Citation
Price AJ, Webb J, Topf H, Dodd CA, Goodfellow JW, Murray DW; Oxford Hip and Knee Group. Rapid recovery after oxford unicompartmental arthroplasty through a short incision. J Arthroplasty. 2001 Dec;16(8):970-6. doi: 10.1054/arth.2001.25552.
Results Reference
background
PubMed Identifier
8895642
Citation
Kreibich DN, Vaz M, Bourne RB, Rorabeck CH, Kim P, Hardie R, Kramer J, Kirkley A. What is the best way of assessing outcome after total knee replacement? Clin Orthop Relat Res. 1996 Oct;(331):221-5. doi: 10.1097/00003086-199610000-00031.
Results Reference
background

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Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

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