Oxford Unicompartmental Knee Arthroplasty With and Without Navigational Unit

NCT ID: NCT00862316

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-05-31

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.

Conditions

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Knee Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Computer Navigational Unit Assistance

Oxford Unicompartmental Knee arthroplasty will be performed with the assistance of a computer navigational unit.

Group Type EXPERIMENTAL

Oxford Unicompartmental Knee

Intervention Type DEVICE

Knee Arthroplasty

Non- Computer Navigational Unit Assisted

Oxford Unicompartmental Knee arthroplasty will be performed traditionally (without the assistance of a computer navigational unit).

Group Type ACTIVE_COMPARATOR

Oxford Unicompartmental Knee

Intervention Type DEVICE

Knee Arthroplasty

Interventions

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Oxford Unicompartmental Knee

Knee Arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* symptomatic unicompartmental knee arthritis major surgery
* failed non operative treatment modalities
* willing and able to give informed consent
* skeletal maturity

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth General Hospital

OTHER

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikram Venugopal, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dartmouth General Hospital

Locations

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Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 11284563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9853489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11740750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8895642 (View on PubMed)

Other Identifiers

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CA4

Identifier Type: -

Identifier Source: org_study_id

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