Oxford Partial Knee Comparative Instrument Pilot Study
|Osteoarthritis, Knee||Procedure: Conventional Instrumentation Procedure: Signature Custom Guides|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Comparison of Signature Guides and Conventional Instrumentation With the Oxford Partial Knee System Pilot Study|
- Oxford Knee Score [ Time Frame: Two Years ]The Oxford Knee Score is a patient administered questionnaire about how they are functioning and feel about their knee.
- Average Operative Time [ Time Frame: 1 Year ]From incision to incision closure.
|Study Start Date:||June 2013|
|Study Completion Date:||December 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Conventional Oxford instrumentation
Patients who receive an Oxford Partial Knee with Conventional instrumentation.
Procedure: Conventional Instrumentation
Standard Oxford surgical instruments
Experimental: Signature Guides Oxford
Patients who receive an Oxford Partial Knee with Signature Custom Guides
Procedure: Signature Custom Guides
Signature Custom Guides used with Instruments in surgical technique
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and Conventional Instrumentation.
The FDA has approved the Oxford Partial Knee via Premarket Approval P010014. Also, by being CE marked, the Oxford Partial Knee also conforms to the essential requirements of EC Directive 93/42/EEC; in accordance to 13485:2003. The data gathered will be collated and used to provide feedback to design engineers, support marketing efforts, answer potential questions from reimbursement agencies, and will serve as a part of Biomet's Post Market Surveillance System.
Surgical techniques and patient care are to be standard for the surgeon participating in the protocol for both treatment groups and should be maintained the same throughout the course of the data-collection. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling. Any use of the device or collection of clinical data outside of the United States should comply with all local, state, and/or national and international regulations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410786
|Leinster Orthopaedic Centre|
|Christchurch, New Zealand|
|Study Director:||Russell Schenck, Ph.D.||Zimmer Biomet|