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Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00862316
Enrollment
48
Registered
2009-03-16
Start date
2009-05-31
Completion date
2010-05-31
Last updated
2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthritis

Keywords

Eligible for Unicompartmental Knee Arthritis

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.

Interventions

DEVICEOxford Unicompartmental Knee

Knee Arthroplasty

Sponsors

Dartmouth General Hospital
CollaboratorOTHER
Zimmer Biomet
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Operative recordImmediately Post-Op
Visual Analogue for pain, activity, and patient satisfaction (VAS)1 year
American Knee Society Score (AKSS)1 year

Secondary

MeasureTime frame
Gait Belt Analysis1 year
Oxford Knee 121 year
Radiographic Output1 year
Western Ontario MacMaster(WOMAC)1 year
SF 121 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026