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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00862316
Other study ID # CA4
Secondary ID
Status Completed
Phase N/A
First received February 3, 2009
Last updated June 15, 2017
Start date May 2009
Est. completion date May 2010

Study information

Verified date June 2017
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Oxford Unicompartmental Knee
Knee Arthroplasty

Locations

Country Name City State
Canada Dartmouth General Hospital Dartmouth Nova Scotia

Sponsors (2)

Lead Sponsor Collaborator
Zimmer Biomet Dartmouth General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Svärd 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Operative record Immediately Post-Op
Primary Visual Analogue for pain, activity, and patient satisfaction (VAS) 1 year
Primary American Knee Society Score (AKSS) 1 year
Secondary Oxford Knee 12 1 year
Secondary Western Ontario MacMaster(WOMAC) 1 year
Secondary SF 12 1 year
Secondary Gait Belt Analysis 1 year
Secondary Radiographic Output 1 year
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