Clinical trial NCT00862316: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthritis
Keywords: Eligible for Unicompartmental Knee Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Dartmouth General Hospital
First posted: 2009-03-16
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Operative record
timeFrame: Immediately Post-Op
measure: Visual Analogue for pain, activity, and patient satisfaction (VAS)
timeFrame: 1 year
measure: American Knee Society Score (AKSS)
timeFrame: 1 year
Secondary outcomes:
measure: Oxford Knee 12
timeFrame: 1 year
measure: Western Ontario MacMaster(WOMAC)
timeFrame: 1 year
measure: SF 12
timeFrame: 1 year
measure: Gait Belt Analysis
timeFrame: 1 year
measure: Radiographic Output
timeFrame: 1 year
Other outcomes:
Locations:
city: Dartmouth
country: Canada
facility: Dartmouth General Hospital
state: Nova Scotia
Study officials:
affiliation: Dartmouth General Hospital
name: Vikram Venugopal, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.