Back to resultsOxford Partial Knee Kinematics Gait Analysis Study
Primary Purpose
Medial Knee Compartment Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxford Partial Knee
Sponsored by
About this trial
This is an interventional treatment trial for Medial Knee Compartment Arthritis focused on measuring partial knee arthroplasty
Eligibility 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.).
Sites / Locations
- SHRI-CORE Orthopedic Research Lab
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Partial Knee Arthroplasty
Arm Description
Oxford Mobile Bearing Unicompartmental Knee Arthroplasties
Outcomes
Primary Outcome Measures
Knee Society Score (KSS)
Secondary Outcome Measures
Range of Motion (ROM)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01454908
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, and Stair Climbing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The CORE Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Knee Compartment Arthritis
Keywords
partial knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Partial Knee Arthroplasty
Arm Type
Other
Arm Description
Oxford Mobile Bearing Unicompartmental Knee Arthroplasties
Intervention Type
Device
Intervention Name(s)
Oxford Partial Knee
Intervention Description
The Oxford partial knee contains tibial and medial components and a mobile meniscal bearing.
Primary Outcome Measure Information:
Title
Knee Society Score (KSS)
Time Frame
up to 1 month pre-operatively and at 1 year post operatively
Secondary Outcome Measure Information:
Title
Range of Motion (ROM)
Time Frame
up to 1 month pre-operatively and at 1 year post operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.).
Facility Information:
Facility Name
SHRI-CORE Orthopedic Research Lab
City
Sun City West
State/Province
Arizona
ZIP/Postal Code
85375
Country
United States
12. IPD Sharing Statement
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Oxford Partial Knee Kinematics Gait Analysis Study
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