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SOS


Title Orthopaedic Sports Medicine, Arthoscopy, and Related Surgery Registry Using the Web-Based Surgical Outcomes System
Therapeutic Area Orthopaedic Surgery
Principal Investigator Matthew Salzler, MD
Min Age 12 Years
Gender Any
Contact Molly Clark
617-636-5159
mclark@tuftsmedicalcenter.org

Overview

The purpose of this study is to establish a large, international, web based registry, using the Surgical Outcomes System (SOS), to collect baseline characteristics of patients undergoing orthopaedic and sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and costs-effectiveness associated with the surgical procedures. Additionally, baseline and outcome data for non-operative treatment procedures will b collected using the same measures in order to compare to surgical outcomes.

Health care providers participate in the SOS registry for the primary purpose of tracking their patient's outcomes and evaluating the global outcomes of various standard of care orthopaedic and sports medicine medical procedures, in order to develop evidence based protocols fo the best methods for treating patients with different conditions. The sponsor, Arthrex, uses the protected health information submitted from the health care providers to create aggregated healthcare provider and de-identified global averages. The de-identified global data is shared with all participants. Healthcare providers use this information to perform healthcare operations including outcomes evaluation and development of clinical guidelines. The aggregated data provide orthopaedic and sport medicine healthcare providers' feedback on their patient's outcomes relative to global benchmarks.

Secondarily, healthcare providers participate in the SOS registry for the purposes of analyzing and publishing outcomes of specific standards of care procedures, techniques, devices/biologics (i.e."research"), as well as to utilize the de-identified data for patient education of expected outcomes and to provide evidence of successful surgical/treatment outcomes to their peers and future patients. Except for technical and system functionality purposes (for example, registry maintenance, data aggregation, and de-identification), the sponsor only views and uses the global de-identified global dataset. Arthrex uses the global de-identified data for the purposes of international product approval, internal research and product develop, and marketing. healthcare providers participating in the SOS registry for primary and secondary research purposes are designated as study doctors in this protocol.

Only data associated with labeled indications of approved or cleared orthopedic devices and/or biologics are intended to be collected. Data will be collected from the subject and study doctor, who is the same person as the subjection's treating physician, by completing data fields and surveys on a web based secure site, which is maintained by the sponsor. From the information collected and analyzed in this study the study doctors and study sponsor hope to learn more about the cost-effectiveness of surgical and non-operative interventions and subjects' pain, function and well-being before and after treatment. The sponsor, Arthrex Inc., manufactures medical devices for orthopedic sports medicine and arthroscopy that may be used in the subjects' surgery. Arthrex does not participate in the study doctor's selection or provision of treatment for any specific subject, including the selection medical device.

Study Details

Inclusion Criteria

  • ≥ 12 years of age, presenting to the clinic and electing to schedule routine and medically indicated orthopedic and sports medicine surgery, or a non-operative treatment option by a participating Surgical Outcomes System (SOS) study doctor.

Exclusion Criteria

  • Patients not capable of completing the English or Spanish language surveys.
  • Vulnerable populations, with the exception of minors.   Including:
    • Pregnant women
    • nursing home residents
    • the study doctor's students and employees
    • those unable to consent for themselves
    • others who could be subject to coercion.
  • Subject unwilling or unable to complete their surveys.

Study Requirements

Subjects have to be willing to participate and enroll int eh study which will mean that the subject's de-identified data will be captured and used for research and development.   The subjects will also be required to complete automatic personalized emails fo surveys from the Physician.