Official Title: “Investigation of Unicompartmental Knee Arthroplasty and Functional, Daily Activities: A Quantitative Assessment of Gait, Sit-to-Stand Activities, and Stair Climbing”

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.

Study Type: Observational

Study Design: Other, Prospective

Intervention(s) in this Clinical Trial

• Device: Oxford® Partial Knee
  • The Oxford® Partial Knee contains tibial and medial components and a mobile meniscal bearing.
• Device: Vanguard™ Complete Knee System
  • This is a total knee system.

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • 25 Oxford Mobile Bearing Unicompartmental Knee Arthroplasties
• : 2
  • 25 Vanguard Total Knee Arthroplasties

Primary Measures

• Qualitative assessment of gait, stair climbing, and rising from a chair
  • Time Frame: Study Completion
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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.)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Kristine Csavina, PhD Principal Investigator The CORE Institute  

Overall Contact: Kristine Csavina, PhD 623-537-5695 research@thecoreinstitute.org

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576966

Study ID Number: 100-U-005

ClinicalTrials.gov Identifier: NCT00576966

Health Authority: United States: Institutional Review Board