Text Size

Oxford Partial Knee Kinematics Gait Analysis Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The CORE Institute
ClinicalTrials.gov Identifier:
NCT01454908
First received: October 13, 2011
Last updated: October 18, 2011
Last verified: October 2011
History of Changes
  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: 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:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: The CORE Institute
ClinicalTrials.gov Identifier: NCT01454908     History of Changes
Obsolete Identifiers: NCT00576966
Other Study ID Numbers: 100-U-005
Study First Received: October 13, 2011
Last Updated: October 18, 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 May 16, 2013