Status:
RECRUITING
Exactech Shoulder Post Market Clinical Follow-up Study
Lead Sponsor:
Exactech
Conditions:
Osteo Arthritis Shoulders
Osteonecrosis
Eligibility:
All Genders
21+ years
Brief Summary
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...
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)
Key Trial Info
Start Date :
July 19 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
20000 Patients enrolled
Trial Details
Trial ID
NCT05603728
Start Date
July 19 2007
End Date
December 31 2031
Last Update
December 15 2025
Active Locations (38)
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1
South County Orthopedic Specialists
Laguna Woods, California, United States, 92637
2
Stanford Health Care
Redwood City, California, United States, 94063
3
Alpine Orthopaedic Medical Group
Stockton, California, United States, 95204-5508
4
Western Orthopaedics
Denver, Colorado, United States, 80218