Exactech Shoulder Post Market Clinical Follow-up Study
Recruiting · NCT05603728 · Observational (researchers observe without assigning treatment) · Lead sponsor: Exactech
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
60 locations listed across 13 US states.
- South County Orthopedic Specialists - Laguna Woods, California, United States
- South County Orthopedic Specialists - Laguna Woods, California, United States
- Stanford Health Care - Redwood City, California, United States
- Stanford Health Care - Redwood City, California, United States
- Alpine Orthopaedic Medical Group - Stockton, California, United States
- Alpine Orthopaedic Medical Group - Stockton, California, United States
- Western Orthopaedics - Denver, Colorado, United States
- Western Orthopaedics - Denver, Colorado, United States
- Orthopaedic and Spine Center of the Rockies - Fort Collins, 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
- UF Health Orthopaedics and Sports Medicine Institute - Gainesville, Florida, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Florida Atlantis Orthopedics - 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
- Orthopaedic Medical Group of Tampa Bay - Tampa, Florida, United States
- HSS Florida - West Palm Beach, Florida, United States
- HSS Florida - West Palm Beach, Florida, United States
- Orthopedic and Sports Medicine - Augusta, Georgia, United States
- Orthopedic and Sports Medicine - Augusta, Georgia, United States
- OrthoIllinois - Rockford, Illinois, United States
- OrthoIllinois - Rockford, Illinois, United States
- Barrington Orthpedic Specialists - Schaumburg, Illinois, United States
- Barrington Orthpedic Specialists - Schaumburg, Illinois, United States
- Henry Ford Health - Detroit, Michigan, 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
- 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
- Southeastern Sports Medicine and Orthopedics - Asheville, North Carolina, United States
- Duke Department of Orthopedic Surgery - Durham, North Carolina, United States
- Duke Department of Orthopedic Surgery - Durham, North Carolina, United States
- Crystal Clinic Orthopaedic - Akron, Ohio, United States
- Crystal Clinic Orthopaedic - Akron, Ohio, United States
- Charleston Orthopaedic Associates - Charleston, South Carolina, United States
- Charleston Orthopaedic Associates - Charleston, South Carolina, United States
- Steadman Hawkins Clinic of the Carolinas - Greenville, South Carolina, United States
- Steadman Hawkins Clinic of the Carolinas - Greenville, South Carolina, United States
- Bone and Joint Institute of Tenessee - Franklin, Tennessee, United States
- Bone and Joint Institute of Tenessee - Franklin, Tennessee, United States
- Atlantic Orthopaedics Specialists - Virginia Beach, Virginia, United States
- Atlantic Orthopaedics Specialists - Virginia Beach, Virginia, United States
- Orthopaedic Associates of Wisconsin - Pewaukee, Wisconsin, United States
- Orthopaedic Associates of Wisconsin - Pewaukee, Wisconsin, United States
- The Sulis Hospital Bath - Bath, United Kingdom
- The Sulis Hospital Bath - Bath, United Kingdom
- Bedford Hospital - Bedford, United Kingdom
- Bedford Hospital - Bedford, United Kingdom
- Policlinico Morgagni - Catania, Italy
- Policlinico Morgagni - Catania, Italy
- Campolongo Hospital - Eboli, Italy
- Campolongo Hospital - Eboli, Italy
- Malteser Waldkrankenhaus Erlangen - Erlangen, Germany
- Malteser Waldkrankenhaus Erlangen - Erlangen, Germany
- Clinique Belledone - Grenoble, France
- Clinique Belledone - Grenoble, France
Showing 60 of 80 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →