Exactech Shoulder Post Market Clinical Follow-up Study

Recruiting now

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

In brief

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.

Key facts

Study ID

NCT05603728

Run by

Exactech

People needed

20000

Starts

2007-07-19

Expected to finish

2031-12-31

Last updated by the study team

2025-12-15

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• South County Orthopedic Specialists — Laguna Woods, California, United States (enrolling)
• Stanford Health Care — Redwood City, California, United States (enrolling)
• Alpine Orthopaedic Medical Group — Stockton, California, United States (enrolling)
• Western Orthopaedics — Denver, Colorado, United States (enrolling)
• Orthopaedic and Spine Center of the Rockies — Fort Collins, Colorado, United States (enrolling)
• UF Health Orthopaedics and Sports Medicine Institute — Gainesville, Florida, United States (enrolling)
• Mayo Clinic — Jacksonville, Florida, United States (enrolling)
• Palm Beach Orthopaedic Institute — Palm Beach Gardens, Florida, United States (enrolling)
• Florida Atlantis Orthopedics — Palm Beach Gardens, Florida, United States (enrolling)
• Orthopaedic Medical Group of Tampa Bay — Tampa, Florida, United States (enrolling)
• Orthopedic and Sports Medicine — Augusta, Georgia, United States (enrolling)
• OrthoIllinois — Rockford, Illinois, United States (enrolling)
• Barrington Orthpedic Specialists — Schaumburg, Illinois, United States (enrolling)
• Henry Ford Health — Detroit, Michigan, United States (enrolling)
• Hospital for Joint Diseases - NYU Langone Health — New York, New York, United States (enrolling)
• Lenox Health Greenwich Village — New York, New York, United States (enrolling)
• Southeastern Sports Medicine and Orthopedics — Asheville, North Carolina, United States (enrolling)
• Duke Department of Orthopedic Surgery — Durham, North Carolina, United States (enrolling)
• Crystal Clinic Orthopaedic — Akron, Ohio, United States (enrolling)
• Charleston Orthopaedic Associates — Charleston, South Carolina, United States (enrolling)
• Steadman Hawkins Clinic of the Carolinas — Greenville, South Carolina, United States (enrolling)
• Bone and Joint Institute of Tenessee — Franklin, Tennessee, United States (enrolling)
• Atlantic Orthopaedics Specialists — Virginia Beach, Virginia, United States (enrolling)
• Orthopaedic Associates of Wisconsin — Pewaukee, Wisconsin, United States (enrolling)
• St Joseph's Health Care — London, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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