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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.

Official Title

Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Reverse Should System

Details

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total 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 Reverse Shoulder System.

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 Reverse Shoulder System.

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 analysis of x-rays.

Keywords

Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis Ununited Humeral Head Fracture Irreducible 3-and 4-part Proximal Humeral Fractures Avascular Necrosis Gross Rotator Cuff Deficiency Failed Total Shoulder Arthroplasty (Both Glenoid and Humeral Components Require Revision Reverse Total Shoulder Arthroplasty Reverse TSA

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient is > 18 years of age;
  • Patient is skeletally mature;
  • Patient qualifies for primary or revision unilateral or bilateral reverse total shoulder arthroplasty based on physical exam and medical history including the following: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, ununited humeral head fracture, irreducible 3-and 4-part proximal humeral fractures, avascular necrosis, gross rotator cuff deficiency or failed total shoulder arthroplasty (both glenoid and humeral components require revision);
  • Patient is willing and able to provide written informed consent;
  • Patient is willing and able to cooperate in the required post-operative therapy;
  • Patient is willing and able to complete scheduled follow-up evaluations/questionnaires as described in the Informed Consent;
  • Patient has participated in the Informed Consent process and has signed the IRB/ERB approved informed consent.

You CAN'T join if...

  • The patient is a prisoner;
  • The patient is mentally incompetent or unable to understand what participation in the study entails;
  • The patient is a known alcohol or drug abuser;
  • The patient is anticipated to be non-compliant;
  • The patient has one of the following compromising the affected limb: a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;
  • The patient has a local/systemic infection;
  • The patient is known to be pregnant;
  • The patient has marked bone loss;
  • The patient has a known sensitivity or allergic reaction to one or more of the implanted materials;
  • The patient is unwilling or unable to give consent or to comply with the follow-up program.

Locations

  • Washington University in St. Louis
    St. Louis, Missouri, 63110, United States
  • Norton Orthopaedic & Sports Medicine
    Louisville, Kentucky, 40241, United States
  • The Rothman Institute
    Philadelphia, Pennsylvania, 19107, United States
  • The Rothman Institute
    Egg Harbor Township, New Jersey, 08234, United States
  • Royal Blackburn Hospital
    Blackburn, Lancashire, BB2 3HH, United Kingdom

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Zimmer Biomet
ID
NCT01480440
Study Type
Observational
Last Updated
January 1, 2017