Home › Trials › NCT05603728

Long-term follow-up on shoulder arthroplasty outcomes

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

Observational Exactech · NCT05603728

This study is looking at how well shoulder replacement surgery works over time by following patients for at least 10 years to see how they feel and how their shoulders are doing.

Quick facts

Study typeObservational
Enrollment20000 (estimated)
Ages21 Years and up
SexAll
SponsorExactech Industry-sponsored
Locations38 sites (Laguna Woods, California and 37 other locations)
Trial IDNCT05603728 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients indicated for shoulder arthroplasty who are skeletally mature and expected to survive at least two years post-surgery.

Not a fit: Patients with significant bone loss, infections, or neuromuscular disorders affecting joint control may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of shoulder arthroplasty outcomes, leading to improved patient care and surgical techniques.

How similar studies have performed: Other studies have shown success in evaluating long-term outcomes of orthopedic procedures, suggesting this approach is well-established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Laguna Woods, California and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Osteo Arthritis ShouldersOsteonecrosisRotator Cuff TearsRotator Cuff Tear ArthropathyAnkylosing SpondylitisPost-traumatic OsteoarthritisRheumatoid ArthritisFracture
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.