NCT00862316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

February 3, 2009

Last Update Submit

June 15, 2017

Conditions

Knee Arthritis

Keywords

Eligible for Unicompartmental Knee Arthritis

Outcome Measures

Primary Outcomes (3)

  • Operative record

    Immediately Post-Op

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

    1 year

  • American Knee Society Score (AKSS)

    1 year

Secondary Outcomes (5)

  • Oxford Knee 12

    1 year

  • Western Ontario MacMaster(WOMAC)

    1 year

  • SF 12

    1 year

  • Gait Belt Analysis

    1 year

  • Radiographic Output

    1 year

Study Arms (2)

Computer Navigational Unit Assistance

EXPERIMENTAL

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

Device: Oxford Unicompartmental Knee

Non- Computer Navigational Unit Assisted

ACTIVE COMPARATOR

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

Device: Oxford Unicompartmental Knee

Interventions

Oxford Unicompartmental KneeDEVICE

Knee Arthroplasty

Computer Navigational Unit AssistanceNon- Computer Navigational Unit Assisted

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

Location

Related Publications (4)

  • 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.

    PMID: 11284563BACKGROUND

  • 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.

    PMID: 9853489BACKGROUND

  • 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.

    PMID: 11740750BACKGROUND

  • 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.

    PMID: 8895642BACKGROUND

Study Officials

  • Vikram Venugopal, Dr.

    Dartmouth General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

March 16, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

CA(1)