Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01480453|
Recruitment Status : Recruiting
First Posted : November 28, 2011
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment|
|Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Ununited Humeral Head Fracture Irreducible 3- and 4-part Proximal Humeral Fractures Avascular Necrosis||Device: Trabecular Metal Humeral Stem|
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Humeral Stem.
Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular Metal Humeral Stem.
Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the SF-12 as well as AEs and radiographic parameters by analysis of x-rays.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Retrospective and Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Humeral Stem|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
Trabecular Metal Humeral Stem
Patients requiring primary, total or hemi shoulder arthroplasty who receive the Trabecular Metal Humeral Stem.
Device: Trabecular Metal Humeral Stem
Trabecular Metal Humeral Stem used in primary, total or hemi shoulder arthroplasty
- Survivorship [ Time Frame: 10 Years ]Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
- Pain and Functional Performance [ Time Frame: 10 Years ]Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE)
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): NCT01480453
|Contact: Jeff Schram, BS, MSemail@example.com|
|Contact: Kelly Francher, BA, CCRAfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Withdrawn|
|San Francisco, California, United States, 94143|
|United States, Kentucky|
|Norton Orthopaedic Specialists||Recruiting|
|Louisville, Kentucky, United States, 40241|
|Contact: Barbara Patterson 502-629-3219 email@example.com|
|Principal Investigator: Ryan Krupp, MD|
|United States, Michigan|
|William Beaumont Hospital||Recruiting|
|Royal Oak, Michigan, United States, 48073|
|Contact: Jerome M Wiater, MD 248-644-3920 Mwiater@beaumont.edu|
|Contact: Lauren Davey 248-551-2313 Lauren.Davey@beaumont.org|
|Principal Investigator: Jerome M Wiater, MD|
|United States, Pennsylvania|
|The Rothman Institute||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Thema Nicholson firstname.lastname@example.org|
|Principal Investigator: Joseph Abboud, MD|
|Canada, British Columbia|
|University of British Columbia Hospital, Vancouver||Withdrawn|
|Vancouver, British Columbia, Canada, V6T 2B5|