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Oxford Partial Knee Kinematics Gait Analysis Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by The CORE Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454908
First Posted: October 19, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The CORE Institute
  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 Knee Compartment Arthritis Device: Oxford Partial Knee

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Unicompartmental Knee Arthroplasty and Functional, Daily Activities: A Quantitative Assessment of Gait, Sit-to-Stand, and Stair Climbing

Resource links provided by NLM:


Further study details as provided by The CORE Institute:

Primary Outcome Measures:
  • Knee Society Score (KSS) [ Time Frame: up to 1 month pre-operatively and at 1 year post operatively ]

Secondary Outcome Measures:
  • Range of Motion (ROM) [ Time Frame: up to 1 month pre-operatively and at 1 year post operatively ]

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
Partial Knee Arthroplasty
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with medial knee 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 a diagnosed disorder with gait disturbance (e.g. lower extremity weakness, prior lower extremity arthrodesis, diagnosed movement disorders, etc.).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454908


Locations
United States, Arizona
SHRI-CORE Orthopedic Research Lab
Sun City West, Arizona, United States, 85375
Sponsors and Collaborators
The CORE Institute
  More Information

Responsible Party: The CORE Institute
ClinicalTrials.gov Identifier: NCT01454908     History of Changes
Obsolete Identifiers: NCT00576966
Other Study ID Numbers: 100-U-005
First Submitted: October 13, 2011
First Posted: October 19, 2011
Last Update Posted: October 12, 2017
Last Verified: October 2011

Keywords provided by The CORE Institute:
partial knee arthroplasty