Knee Arthritis Clinical Trial
Official title:
Outcome Analysis of the Oxford Unicompartmental Knee Arthroplasty With and Without the Assistance of a Computer Navigational Unit
Verified date | June 2017 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Dartmouth General Hospital | Dartmouth | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet | Dartmouth General Hospital |
Canada,
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
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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