Exactech Shoulder Post Market Clinical Follow-up Study

Exactech

Status: Enrolling

Conditions: Post-traumatic Osteoarthritis; Osteo Arthritis Shoulders; Fracture; Osteonecrosis; Infections; Rotator Cuff Tear Arthropathy; Ankylosing Spondylitis; Rheumatoid Arthritis; Rotator Cuff Tears

Study type: Observational

Funder types: Industry

Identifiers

NCT05603728

CR09-005

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)