Taking people in ItalyNo phase
Follows people with shoulder joint replacements over many years
Studies how shoulder replacement implants perform over at least 10 years in adults.
Key facts
- Who runs it
- Exactech
- Where
- Catania and Eboli, ItalySee the 2 sitesAlso in 5 other countries, 38 sites
- Trial code
- Registry title
- Exactech Shoulder Post Market Clinical Follow-up Study
- Status
- Recruiting
- People taking part
- 20,000 people, planned
- Started
- 19 Jul 2007
- Expected to end
- 31 Dec 2031
- Type of study
- Observational
- Record updated
- 17 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need shoulder replacement surgery or have already had it. They will be followed for at least 10 years to see how the implant works.
- Age
- 21 years or older; the bone must be fully grown.
- Sex
- All sexes can join.
- Disease stage
- People who are indicated for shoulder arthroplasty (shoulder replacement), or who have already had it.
- Earlier treatment
- Some people who already had shoulder replacement can join. Revision cases where a stemmed humeral component was used are excluded for the Stemless Shoulder System.
Main reasons for not taking part
- Bone infection of the upper arm bone or shoulder blade, or a suspected or confirmed infection
- Bone that is too weak or malformed to hold the implant
- Nerve or muscle problems: neuromuscular disorders, significant brachial plexus injury, non-functional deltoid muscles
- Alcohol, drug or other substance abuse
- Pregnant people and prisoners
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Where in Italy
Also in 5 other countries, 38 sites
- Policlinico MorgagniCatania, ItalyContact: Gionacchino ZappullaTaking people
- Campolongo HospitalEboli, ItalyContact: Francesco AscioneTaking people
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
- Plain-language title
- Follows people with shoulder joint replacements over many yearsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 September 2026