Oxford Partial Knee Comparative Instrument Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01410786
First received: July 14, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Osteoarthritis, Knee
Procedure: Conventional Instrumentation
Procedure: Signature Custom Guides

Study Type: Interventional
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

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Oxford Knee Score [ Time Frame: Two Years ] [ Designated as safety issue: No ]
    The Oxford Knee Score is a patient administered questionnaire about how they are functioning and feel about their knee.


Secondary Outcome Measures:
  • Average Operative Time [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    From incision to incision closure.


Estimated Enrollment: 70
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Outside the United States:

-The Oxford Partial Knee System is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement (in the United States). Use of cementless femoral fixation is permitted outside of the United States only (if it complies with all local, state, and/or national and international regulations), however the same technique must be used consistently throughout the course of the study (cemented or cementless).

Exclusion Criteria:

  • The exclusion criteria will include the same contraindications stated in the FDA approved labeling for the device (approved in PMA P010014). These contraindications include:
  • Infection, sepsis, and osteomyelitis
  • Use in the lateral compartment of the knee
  • Rheumatoid arthritis or other forms of inflammatory joint disease
  • Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
  • Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
  • Disease or damage to the lateral compartment of the knee
  • Uncooperative patient or patient with neurologic disorders who is incapable of following directions
  • Osteoporosis
  • Metabolic disorders which may impair bone formation
  • Osteomalacia
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy, neuromuscular disease
  • Incomplete or deficient soft tissue surrounding the knee
  • Charcot's disease
  • A fixed varus deformity (not passively correctable) of greater than 15 degrees
  • A flexion deformity greater than 15 degrees
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410786

Contacts
Contact: Nerida Hunt nerida.hunt@biomet.com

Locations
New Zealand
Leinster Orthopaedic Centre Recruiting
Christchurch, New Zealand
Contact: Nerida Hunt       nerida.hunt@biomet.com   
Sponsors and Collaborators
Biomet, Inc.
Investigators
Study Director: Russell Schenck, Ph.D. Biomet, Inc.
  More Information

Publications:
Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01410786     History of Changes
Other Study ID Numbers: 407
Study First Received: July 14, 2011
Last Updated: May 19, 2014
Health Authority: New Zealand: Food Safety Authority
New Zealand: Health Research Council
New Zealand: Health and Disability Ethics Committees

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014