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
Recruitment status was Not yet recruiting
Sponsor:
Knoxville Orthopedic Clinic
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
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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
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 May 21, 2013