Oxford Partial Knee Comparative Instrument Pilot Study
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|ClinicalTrials.gov Identifier: NCT01410786|
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : August 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: Conventional Instrumentation Procedure: Signature Custom Guides||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Comparison of Signature Guides and Conventional Instrumentation With the Oxford Partial Knee System Pilot Study|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||December 2015|
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
- 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.
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): NCT01410786
|Leinster Orthopaedic Centre|
|Christchurch, New Zealand|
|Principal Investigator:||Rod Maxwell||Canterbury Orthopaedic Services|