Total Shoulder Arthroplasty Multi-Center Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03511586

Enrollment

2500

Registered

2018-04-30

Start date

2015-07-28

Completion date

2035-11-01

Last updated

2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Arthroplasty

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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 (not required for acute humeral fractures).

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Pain	10 years	Measure of pain intensity. This is done with the Visual Analog Scare. (VAS)

Countries

Germany, Switzerland, United Kingdom, United States

Contacts

CONTACTKelly Ganz, BA, CCRC

kelly.ganz@arthrex.com1 (800) 933-7001

CONTACTAlicia Ruiz, MS, CCRP, CCRA

alicia.ruiz@arthrex.com1 (800) 933-7001

Outcome results