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RECRUITINGOBSERVATIONAL

Exactech Shoulder Post Market Clinical Follow-up Study

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form Who Should NOT Join This Trial: - 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 (20)

South County Orthopedic Specialists
Laguna Woods, California, United States
Stanford Health Care
Redwood City, California, United States
Alpine Orthopaedic Medical Group
Stockton, California, United States
Western Orthopaedics
Denver, Colorado, United States
Orthopaedic and Spine Center of the Rockies
Fort Collins, Colorado, United States
UF Health Orthopaedics and Sports Medicine Institute
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Palm Beach Orthopaedic Institute
Palm Beach Gardens, Florida, United States
Florida Atlantis Orthopedics
Palm Beach Gardens, Florida, United States
Orthopaedic Medical Group of Tampa Bay
Tampa, Florida, United States
Orthopedic and Sports Medicine
Augusta, Georgia, United States
OrthoIllinois
Rockford, Illinois, United States
Barrington Orthpedic Specialists
Schaumburg, Illinois, United States
Henry Ford Health
Detroit, Michigan, United States
Hospital for Joint Diseases - NYU Langone Health
New York, New York, United States
Lenox Health Greenwich Village
New York, New York, United States
Southeastern Sports Medicine and Orthopedics
Asheville, North Carolina, United States
Duke Department of Orthopedic Surgery
Durham, North Carolina, United States
Crystal Clinic Orthopaedic
Akron, Ohio, United States
Charleston Orthopaedic Associates
Charleston, South Carolina, United States