Follows people with shoulder joint replacements over many years
Studies how shoulder replacement implants perform over at least 10 years in adults.
Plain-language title generated from the registry record
Registry title: Exactech Shoulder Post Market Clinical Follow-up Study
Key facts
- Where
- Erlangen and Münster, GermanySee the 2 sites
Where in Germany
- Malteser Waldkrankenhaus ErlangenErlangen, GermanyTaking people
- Orthopadische Praxisklinik Von VinckeMünster, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Exactech
- Trial code
- NCT05603728
- Record updated
- 17 September 2026
- Original description
The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.Read full original descriptionShow less
An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.
Inclusion: 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: Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation; Alcohol, drug, or other subtance abuse; Patient is contraindicated for the surgery; 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; Neuromuscular disorders that do not allow control of the joint; Any disease state that could adversaly affect the function or longevity of the implant; 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); Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system; Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis; Medial humeral bone loss resulting in compromised humeral stem fixation; Significant injury to the brachial plexus; Non-functional deltoid muscles; The patient is unwilling or unable to comply with the post-operative care instructions; Patient is pregnant; Patient is a prisoner; Revision cases in which a stemmed humeral component was used (Stemless Shoulder System).