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Exactech Shoulder Post Market Clinical Follow-up Study

RecruitingN/A

Sponsor: Exactech

Conditions: Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Ankylosing Spondylitis

Countries: United States, Canada, France, Italy, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 21 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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)

Locations (38)

Laguna Woods, California, United States
Redwood City, California, United States
Stockton, California, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Palm Beach Gardens, Florida, United States
Palm Beach Gardens, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Rockford, Illinois, United States
Schaumburg, Illinois, United States
Detroit, Michigan, United States
New York, New York, United States
New York, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Akron, Ohio, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Franklin, Tennessee, United States
Virginia Beach, Virginia, United States
Pewaukee, Wisconsin, United States
London, Ontario, Canada
Limoges, France
Mérignac, France
Rennes, France
Catania, Italy
Eboli, Italy
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