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Recruiting

NCT Number: NCT03511586

Total Shoulder Arthroplasty Multi-Center Registry

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

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopädische Chirurgie München (OCM), München, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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

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

Treatment and study plan

Primary outcomes

  1. Change in Pain

    Time frame: 10 years

    Measure of pain intensity. This is done with the Visual Analog Scare. (VAS)

Study contacts

Contact information is provided by the study sponsor or research team.

Alicia Ruiz, MS, CCRP, CCRA

CONTACT

[email protected]

1 (800) 933-7001 ext. 71970

Kelly Ganz, BA, CCRC

CONTACT

[email protected]

1 (800) 933-7001 ext. 71119

Sponsors and collaborators

Lead sponsor

Arthrex, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2035
Study completion
2035
First posted
Apr 30, 2018
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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