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 because the information has not been verified recently.
Verified March 2011 by Knoxville Orthopedic Clinic.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Knoxville Orthopedic Clinic
ClinicalTrials.gov Identifier:
NCT01313741
First received: March 10, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Knoxville Orthopedic Clinic:

Primary Outcome Measures:
  • ASES Scores [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
    Accepted validated clinical outcome measure

  • PENN Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Accepted validated outcome measure

  • Radiographic integration of component [ Time Frame: 2 weeks, 6 weeks, 3 months, 2 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Knoxville Orthopaedic Clinic
ClinicalTrials.gov Identifier: NCT01313741     History of Changes
Other Study ID Numbers: Anchor Peg Study
Study First Received: March 10, 2011
Last Updated: March 10, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 19, 2014