Oxford® Partial Knee Kinematics Gait Analysis Study

This study has been suspended.

( Biomet no longer funding study; Research will continue at site. )

First Received on December 17, 2007. Last Updated on October 17, 2011 History of Changes

Sponsor:	The CORE Institute
Collaborator:	Biomet, Inc.
Information provided by (Responsible Party):	The CORE Institute
ClinicalTrials.gov Identifier:	NCT00576966

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.

Condition	Intervention
Medial Compartment Arthritis	Device: Oxford® Partial Knee

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Investigation of Unicompartmental Knee Arthroplasty and Functional, Daily Activities: A Quantitative Assessment of Gait, Sit-to-Stand Activities, and Stair Climbing

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Further study details as provided by The CORE Institute:

Primary Outcome Measures:

Knee Society Score [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ROM [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Enrollment:	18
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 18 Oxford Mobile Bearing Unicompartmental Knee Arthroplasties	Device: Oxford® Partial Knee The Oxford® Partial Knee contains tibial and medial components and a mobile meniscal bearing.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576966

Locations

United States, Arizona
SHRI-CORE Orthopedic Labs
Sun City West, Arizona, United States, 85375

Sponsors and Collaborators

The CORE Institute

Biomet, Inc.

Investigators

Study Director:

Marc Jacofsky, PhD

The CORE Institute

More Information

No publications provided

Responsible Party:	The CORE Institute
ClinicalTrials.gov Identifier:	NCT00576966 History of Changes
Other Study ID Numbers:	100-U-005
Study First Received:	December 17, 2007
Last Updated:	October 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by The CORE Institute:

Partial Knee Arthroplasty

Additional relevant MeSH terms:

Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 09, 2012