Expired Study
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Sun City West, Arizona 85375


Purpose:

The objective of this study is to compare the effect on gait of unicompartmental knee arthroplasty (UKA), using the Oxford® Partial Knee, versus normal knee.


Criteria:

Inclusion Criteria: - Patients with medial compartment arthritis Exclusion Criteria: - Patients with diagnoses other than osteoarthritis (i.e., rheumatoid arthritis, psoriatic arthritis, etc.) - Patients with significant diseases of other joints of the lower extremity - Patients with diagnoses disorder with gait disturbance (e.g. lower extremity weakness, prior lower extremity arthrodesis, diagnoses movement disorders, etc.)


Study is Available At:


Original ID:

100-U-005


NCT ID:

NCT00576966


Secondary ID:


Study Acronym:


Brief Title:

Oxford® Partial Knee Kinematics Gait Analysis Study


Official Title:

Investigation of Unicompartmental Knee Arthroplasty and Functional, Daily Activities: A Quantitative Assessment of Gait, Sit-to-Stand Activities, and Stair Climbing


Overall Status:

Suspended


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The CORE Institute


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:

Biomet no longer funding study; Research wil


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Marc Jacofsky, PhD
Study Director
The CORE Institute

Study Dates

Start Date:April 2006
Completion Date:December 2012
Completion Type:Anticipated
Primary Completion Date:August 2012
Primary Completion Type:Anticipated
Verification Date:October 2011
Last Changed Date:October 17, 2011
First Received Date:December 17, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:ROM
Time Frame:Study Completion
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Knee Society Score
Time Frame:Study Completion
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Oxford® Partial Knee
Description:The Oxford® Partial Knee contains tibial and medial components and a mobile meniscal bearing.
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1
Description:18 Oxford Mobile Bearing Unicompartmental Knee Arthroplasties

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The CORE Institute
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Biomet, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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