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Exactech Shoulder Post Market Clinical Follow-up Study

NCT05603728 · Exactech
In plain English

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Official title
An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes
About this study
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 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)
Study design
Enrollment target: 20000 participants
Age groups: adult, older_adult
Timeline
Starts: 2007-07-19
Estimated completion: 2031-12-31
Last updated: 2025-12-15
Primary outcomes
  • Constant (Through study completion, an average of 1 per year)
  • ASES (Through study completion, an average of 1 per year)
  • Oxford Score (may be used as an optional form for surgeons in the United Kingdom) (Through study completion, an average of 1 per year)
Sponsor
Exactech · industry
Contacts & investigators
ContactRachael Craig · contact · rachael.craig@exac.com · 352-377-1140
ContactSandrine Angibaud · contact · sandrine.angibaud@exac.com · 352-377-1140
InvestigatorJonathan Wright, MD · principal_investigator, UF Health Orthopaedics and Sports Medicine Institute
InvestigatorYoung Kwon, MD · principal_investigator, Hospital for Joint Diseases - NYU Langone Health
InvestigatorRichard Friedman, MD · principal_investigator, Charleston Orthopaedic Associates
All locations (38)
South County Orthopedic SpecialistsRecruiting
Laguna Woods, California, United States
Stanford Health CareRecruiting
Redwood City, California, United States
Alpine Orthopaedic Medical GroupRecruiting
Stockton, California, United States
Western OrthopaedicsRecruiting
Denver, Colorado, United States
Orthopaedic and Spine Center of the RockiesRecruiting
Fort Collins, Colorado, United States
UF Health Orthopaedics and Sports Medicine InstituteRecruiting
Gainesville, Florida, United States
Mayo ClinicRecruiting
Jacksonville, Florida, United States
Palm Beach Orthopaedic InstituteRecruiting
Palm Beach Gardens, Florida, United States
Florida Atlantis OrthopedicsRecruiting
Palm Beach Gardens, Florida, United States
Orthopaedic Medical Group of Tampa BayRecruiting
Tampa, Florida, United States
Orthopedic and Sports MedicineRecruiting
Augusta, Georgia, United States
OrthoIllinoisRecruiting
Rockford, Illinois, United States
Barrington Orthpedic SpecialistsRecruiting
Schaumburg, Illinois, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
Hospital for Joint Diseases - NYU Langone HealthRecruiting
New York, New York, United States
Lenox Health Greenwich VillageRecruiting
New York, New York, United States
Southeastern Sports Medicine and OrthopedicsRecruiting
Asheville, North Carolina, United States
Duke Department of Orthopedic SurgeryRecruiting
Durham, North Carolina, United States
Crystal Clinic OrthopaedicRecruiting
Akron, Ohio, United States
Charleston Orthopaedic AssociatesRecruiting
Charleston, South Carolina, United States
Steadman Hawkins Clinic of the CarolinasRecruiting
Greenville, South Carolina, United States
Bone and Joint Institute of TenesseeRecruiting
Franklin, Tennessee, United States
Atlantic Orthopaedics SpecialistsRecruiting
Virginia Beach, Virginia, United States
Orthopaedic Associates of WisconsinRecruiting
Pewaukee, Wisconsin, United States
St Joseph's Health CareRecruiting
London, Ontario, Canada
Clinique ChenieuxRecruiting
Limoges, France
Centre de l'arthroseRecruiting
Mérignac, France
Clinique Mutualiste La SagesseRecruiting
Rennes, France
Policlinico MorgagniRecruiting
Catania, Italy
Campolongo HospitalRecruiting
Eboli, Italy
Circle Health GroupRecruiting
Reading, Berks, United Kingdom
Yeovil District Hospital NHS Foundation TrustRecruiting
Yeovil, Summerset, United Kingdom
The Sulis Hospital BathRecruiting
Bath, United Kingdom
Bedford HospitalRecruiting
Bedford, United Kingdom
Ipswich HospitalRecruiting
Ipswich, United Kingdom
Leicester General HospitalRecruiting
Leicester, United Kingdom
University Hospital South ManchesterRecruiting
Manchester, United Kingdom
Nottingham University HospitalRecruiting
Nottingham, United Kingdom
Exactech Shoulder Post Market Clinical Follow-up Study · TrialPath