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This is a 2 Year Follow up Clinical and Radiographic Analysis of a Novel All Polyethelene Glenoid Component in Standard Total Shoulder Arthroplasty.

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Knoxville Orthopedic Clinic.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01313741
First Posted: March 14, 2011
Last Update Posted: March 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Knoxville Orthopedic Clinic
  Purpose
Two hundred patients will be analyzed both clinically (via validated outcomes measures) and radiographically (via 2 sets of standard radiographs) to determine the survival and degree of bone in growth of a novel all polyethelene glenoid component used in a standard FDA approved shoulder arthroplasty system.

Condition Intervention Phase
The Primary Disease Process Being Studied is Shoulder OA and the Effect of an All Polyethelene Glenoid Component on Shoulder Arthroplasty Device: Shoulder arthroplasty with anchor peg glenoid Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Knoxville Orthopedic Clinic:

Primary Outcome Measures:
  • ASES Scores [ Time Frame: Every 3 months ]
    Accepted validated clinical outcome measure

  • PENN Score [ Time Frame: 3 months ]
    Accepted validated outcome measure

  • Radiographic integration of component [ Time Frame: 2 weeks, 6 weeks, 3 months, 2 years ]
    Two sets of radiographs will be obtained to look for any signs of loosening and for bony integration of the component


Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm shoulder arthroplasty Device: Shoulder arthroplasty with anchor peg glenoid
Shoulder arthroplasty with anchor peg glenoid

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: all patients with standard OA who had a shoulder arthroplasty with an anchor peg glenoid -

Exclusion Criteria:Any paient who had a concomitant rotator cuff tear, infection, revision or previous arthroplasty.

  Contacts and Locations
Information from the National Library of Medicine

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): NCT01313741


Contacts
Contact: Edwin E Spencer Jr, MD 865 450 1227 spencer9882@comcast.net
Contact: Jeff G Jarnigan, PA 865 450 1227 jjj@aol.com

Locations
United States, Tennessee
Knoxville Orthopaedic Clinic Not yet recruiting
Knoxville, Tennessee, United States, 37922
Contact: Edwin E Spencer Jr, MD    865-450-1227    spencer9882@comcast.net   
Principal Investigator: Edwin E Spencer Jr, MD         
Sponsors and Collaborators
Knoxville Orthopedic Clinic
  More Information

Additional Information:
Responsible Party: Knoxville Orthopaedic Clinic
ClinicalTrials.gov Identifier: NCT01313741     History of Changes
Other Study ID Numbers: Anchor Peg Study
First Submitted: March 10, 2011
First Posted: March 14, 2011
Last Update Posted: March 14, 2011
Last Verified: March 2011