Oxford® Partial Knee Kinematics Gait Analysis Study - Full Text View

Sponsor:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
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 total knee arthroplasty (TKA), using the Vanguard™ Total Knee System. Specifically quantitative motion analysis will determine the postoperative effect on gait and other activities of daily living. Biomet's Oxford Unicompartmental Knee System is the only fully mobile bearing partial knee system available for use in the United States.

Condition	Intervention
Medial Compartment Arthritis	Device: Oxford® Partial Knee Device: Vanguard™ Complete Knee System

Study Type:	Observational
Study Design:	Prospective
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 Biomet, Inc.:

Primary Outcome Measures:

Qualitative assessment of gait, stair climbing, and rising from a chair [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lower extremity kinematics; Same data will be collected for stair climbing/descending and rising/lowering from a chair; Anthropomorphic measurements; Range of motion; Radiographs; SF-12; Lower extremity activity scale; KSS [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 25 Oxford Mobile Bearing Unicompartmental Knee Arthroplasties	Device: Oxford® Partial Knee The Oxford® Partial Knee contains tibial and medial components and a mobile meniscal bearing.
2 25 Vanguard Total Knee Arthroplasties	Device: Vanguard™ Complete Knee System This is a total knee system.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

There will be three groups in this study with 25 patients in each group.

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

Contacts

Contact: Kristine Csavina, PhD

623-537-5695

research@thecoreinstitute.org

Locations

United States, Arizona
SHRI-CORE Orthopedic Labs	Recruiting
Sun City West, Arizona, United States, 85375
Contact: Kristine Csavina, PhD 623-537-5695 research@thecoreinstitute.org

Sponsors and Collaborators

Biomet Orthopedics, LLC

Investigators

Principal Investigator:

Kristine Csavina, PhD

The CORE Institute

More Information

No publications provided

Responsible Party:	SHRI-CORE Orthopedic Research ( M. Wade Shrader, MD )
Study ID Numbers:	100-U-005
Study First Received:	December 17, 2007
Last Updated:	December 1, 2009
ClinicalTrials.gov Identifier:	NCT00576966 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Biomet, Inc.:

Total Knee Arthroplasty
Partial Knee Arthroplasty

Additional relevant MeSH terms:

Musculoskeletal Diseases
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on February 04, 2010