Long-term follow-up on shoulder arthroplasty outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect and evaluate long-term clinical and radiographic outcomes data to understand the safety and performance of shoulder arthroplasty over time. Participants will be followed for a minimum of 10 years, allowing researchers to gather extensive data on the effectiveness of the procedure. The study includes patients who are indicated for shoulder arthroplasty or have previously undergone the procedure, ensuring a comprehensive assessment of outcomes. By monitoring these patients, the study seeks to provide valuable insights into the long-term success of shoulder surgeries.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
* Patient is skeletelly mature
* Patient is expected to survive at least 2 years beyond surgery
* Patient is willing to participate by complying with pre- and postoperative visit requirements
* Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

* Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
* Medial humeral bone loss resulting in compromised humeral stem fixation
* Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation
* Neuromuscular disorders that do not allow control of the joint
* Significant injury to the brachial plexus
* Non-functional deltoid muscles
* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
* The patient is unwilling or unable to comply with the post-operative care instructions
* Alcohol, drug, or other subtance abuse
* Any disease state that could adversaly affect the function or longevity of the implant
* Patient is pregnant
* Patient is a prisoner
* Patient is contraindicated for the surgery
* Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)
* Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)
* Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)
* Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)

Where it's running

• South County Orthopedic Specialists
  Laguna Woods, California, United States Recruiting
• Stanford Health Care
  Redwood City, California, United States Recruiting
• Alpine Orthopaedic Medical Group
  Stockton, California, United States Recruiting
• Western Orthopaedics
  Denver, Colorado, United States Recruiting
• Orthopaedic and Spine Center of the Rockies
  Fort Collins, Colorado, United States Recruiting
• UF Health Orthopaedics and Sports Medicine Institute
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Jonathan Wright, MD — UF Health Orthopaedics and Sports Medicine Institute
• Study coordinator: Rachael Craig
• Email: rachael.craig@advita.com
• Phone: 1-833-423-8482

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.