Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

Study Overview
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Brief Summary
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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
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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.

Official Title
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Outcome Analysis of the Oxford Unicompartmental Knee Arthroplasty With and Without the Assistance of a Computer Navigational Unit

Conditions
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Knee Arthritis

Intervention / Treatment
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* Device: Oxford Unicompartmental Knee


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer Navigational Unit Assistance<br>Oxford Unicompartmental Knee arthroplasty will be performed with the assistance of a computer navigational unit. | Device: Oxford Unicompartmental Knee<br>* Knee Arthroplasty<br>|
| Active Comparator: Non- Computer Navigational Unit Assisted<br>Oxford Unicompartmental Knee arthroplasty will be performed traditionally (without the assistance of a computer navigational unit). | Device: Oxford Unicompartmental Knee<br>* Knee Arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative record |  | Immediately Post-Op | 
| Visual Analogue for pain, activity, and patient satisfaction (VAS) |  | 1 year | 
| American Knee Society Score (AKSS) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee 12 |  | 1 year | 
| Western Ontario MacMaster(WOMAC) |  | 1 year | 
| SF 12 |  | 1 year | 
| Gait Belt Analysis |  | 1 year | 
| Radiographic Output |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eligible for Unicompartmental Knee Arthritis