Perform Humeral System Study

Description

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

Conditions

Osteoarthritis Shoulder, Avascular Necrosis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Rotator Cuff Tear Arthropathy

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Study Overview

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Study Details

Study overview

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

Perform Humeral System Study

Perform Humeral System Study

Condition
Osteoarthritis Shoulder
Intervention / Treatment

-

Contacts and Locations

Lexington

Baptist Healthcare, Lexington, Kentucky, United States, 40503

Eagan

Summit Orthopedics, Eagan, Minnesota, United States, 55121

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Sioux Falls

Orthopedic Institute, Sioux Falls, South Dakota, United States, 57105

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 years or older at the time of the informed consent or non-opposition (when applicable).
  • * Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
  • * Willing and able to comply with the requirements of the study protocol.
  • * Considered a candidate for shoulder arthroplasty using a study device.
  • * Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements
  • * Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)
  • * Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
  • * Active local or systemic infection, sepsis, or osteomyelitis
  • * Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid
  • * Significant injury to the brachial plexus
  • * Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
  • * Neuromuscular disease (e.g., joint neuropathy)
  • * Patient with known allergy to one of the product materials
  • * Metabolic disorders which may impair bone formation
  • * Patient pregnancy
  • * Planned for two-stage surgery

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stryker Trauma and Extremities,

Rebecca Gibson, STUDY_DIRECTOR, Stryker Trauma

Study Record Dates

2035-12-01