Clinical trial NCT03511586: Total Shoulder Arthroplasty Multi-Center Registry
Official title: Total Shoulder Arthroplasty Multi-Center Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Arthroplasty
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-30
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who are seeking treatment or are undergoing a shoulder replacement procedure utilizing an Arthrex shoulder arthroplasty prostheses are being invited to participate in this research registry.

Brief summary: The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.

Detailed description: The study is a non-randomized multi-center prospective registry and subjects will be treated according to standard of care at each center. Subjects will be approached for participation in this study after they have made the decision to undergo a primary or revision shoulder arthroplasty procedure. The treating surgeon will obtain verbal consent from the patient for a research coordinator to screen for eligibility. Patients who meet all criteria will be offered enrollment into the study. The total enrollment goal is a minimum of 500 anatomic shoulder arthroplasty and 500 reverse shoulder arthroplasty subjects enrolled in the multi-center registry.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patient is between the ages of 18 and 100 years.
3. The patient has a planned primary or revision implantation of an anatomic (hemi-arthroplasty or total arthroplasty) or a reverse shoulder prosthesis system manufactured by Arthrex.
4. Patient has a standard of care preoperative CT taken within 6 months that has been submitted for Arthrex VIP (Virtual Implant Positioning) planning.

Exclusion Criteria

1. Patient has known intentions, obligations, or co-morbidity that would inhibit them from participating in the study.

Primary outcomes:
measure: Change in Pain
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona/Banner Health
state: Arizona
city: Phoenix
country: United States
facility: Banner Medical Group
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Gulf Breeze
country: United States
facility: Andrews Research & Education Foundation
state: Florida
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Columbia
country: United States
state: Missouri
city: New York
country: United States
facility: The Rothman Institute
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Beachwood
country: United States
facility: Cleveland Shoulder Institute
state: Ohio
city: Medford
country: United States
state: Oregon
city: Greenville
country: United States
facility: The Hawkins Foundation
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: München
country: Germany
facility: Orthopädische Chirurgie München (OCM)
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References: