Ortho Research

Clinical Trials

Arthrex Registry

Study Contact:

Kaitlyn Shank 434-243-5653 Lizzie Leitch 434-243-0256

HSR #190043

HSR #190043- Werner

Inclusion Criteria

  • Patient voluntarily consents to participate in the study and has the mental and physical ability to participate in the study, fill out subjective questionnaires, return for follow-up visits, and comply with prescribed post-operative physical therapy.
  • Patient is between the ages of 18 and 100 years.
  • An advanced pre-operative image (CT or MRI) is obtained prior to surgery
  • Subject has failed 6 months of conservative treatment, unless acute humeral fracture, and will be surgically treated with a primary or revision implantation of an anatomic or reverse shoulder prosthesis system manufactured by Arthrex.

Exclusion Criteria

  • Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study
  • The patient has known co-morbidity that would make the subject ineligible for a shoulder arthroplasty procedure
  • Patient declines participating in the study

Study Summary

  • Baseline: Consent, review of inclusion/exclusion criteria, questionnaires, x-ray, register subject in SOS
  • Surgery: surgery data form
  • 6 Week: X-ray
  • 9 Week: Questionnaires (through SOS)
  • 3 Month: X-ray
  • 6 Month: Questionnaires (through SOS)
  • 1, 2, 5, 7, & 10 Year: Shoulder exam, questionnaires (through SOS), x-rays
  • 3, 4, 6, 8, & 9 Year: Questionnaires (through SOS)

Payment

  • $625 total
  • Post-Op, 9-week, 26 week, 1 year, 3 year, 4 year, 6 year, 8 year, and 9 year visits: $25 for each completed visit ($225 for completing all visits)
  • 2 year, 5 year, 7 year, and 10 year visits: $100 for each completed ($400 for completing all visits)

Study Cost Coverage

  • The following procedures/tests, which are being done for research purposes, will be provided at no cost to the patient:
    • Shoulder Exams (and associated clinic visit): 1 year, 2 year, 5 year, 7 year, and 10 year visits
    • X-Rays: 2 year, 5 year, 7 year, and 10 year visits
    • All questionnaires
  • The following are part of your standard of care and will be billed to you/ your health insurance:
    • Shoulder Exams (and associated clinic visit): pre-op and 1 year visits
    • X-Rays: pre-op, 2-6wk, 3 month and 1 year visits
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