Exactech Shoulder Post Market Clinical Follow-up Study
Launched by EXACTECH · Nov 1, 2022
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
The Exactech Shoulder Post Market Clinical Follow-up Study is a clinical trial aimed at understanding how well shoulder replacement surgery works over time for patients with various shoulder conditions, such as arthritis or rotator cuff tears. The study will track participants for at least 10 years to gather information on the safety and effectiveness of the shoulder implant.
To be eligible for the study, participants must be at least 21 years old and need shoulder replacement surgery or have already had the surgery. They should be expected to live for at least two more years after the procedure, and they must agree to follow the study guidelines. Participants will have regular check-ups to assess their progress. It's important to note that certain health conditions, infections, or specific complications may disqualify someone from joining the study. Overall, this trial will help improve the future of shoulder surgeries by providing valuable long-term data.
Gender
ALL
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)
About Exactech
Exactech is a leading orthopedic device company committed to improving patient outcomes through innovative solutions in joint reconstruction, trauma, and spine. With a focus on advanced technologies and extensive clinical research, Exactech develops a comprehensive range of implants and instrumentation designed to enhance surgical precision and postoperative recovery. Their dedication to quality, safety, and efficacy is reflected in their robust clinical trial initiatives, which aim to validate the performance of their products and expand the horizons of orthopedic care. By collaborating with healthcare professionals and institutions, Exactech strives to deliver transformative solutions that empower both surgeons and patients alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Jacksonville, Florida, United States
Leicester, , United Kingdom
Ipswich, , United Kingdom
London, Ontario, Canada
Nottingham, , United Kingdom
Greenville, South Carolina, United States
Limoges, , France
Fort Collins, Colorado, United States
Denver, Colorado, United States
Rockford, Illinois, United States
Bedford, , United Kingdom
Redwood City, California, United States
Rennes, , France
New York, New York, United States
Laguna Woods, California, United States
Gainesville, Florida, United States
Palm Beach Gardens, Florida, United States
Palm Beach Gardens, Florida, United States
Tampa, Florida, United States
Augusta, Georgia, United States
Detroit, Michigan, United States
New York, New York, United States
Asheville, North Carolina, United States
Akron, Ohio, United States
Charleston, South Carolina, United States
Franklin, Tennessee, United States
Virginia Beach, Virginia, United States
Pewaukee, Wisconsin, United States
Cavaillon, , France
Mérignac, , France
Catania, , Italy
Eboli, , Italy
Reading, Berks, United Kingdom
Yeovil, Summerset, United Kingdom
Bath, , United Kingdom
Gloucester, , United Kingdom
Manchester, , United Kingdom
Stockton, California, United States
Schaumburg, Illinois, United States
Durham, North Carolina, United States
Patients applied
Trial Officials
Jonathan Wright, MD
Principal Investigator
UF Health Orthopaedics and Sports Medicine Institute
Young Kwon, MD
Principal Investigator
Hospital for Joint Diseases - NYU Langone Health
Richard Friedman, MD
Principal Investigator
Charleston Orthopaedic Associates
Richard Jones, MD
Principal Investigator
Southeastern Orthopedics and Spine
Howard Routman, DO
Principal Investigator
Florida Atlantis Orthopaedics
Ryan Simovitch, MD
Principal Investigator
Palm Beach Orthopaedic Institute
Geoffrey Abrams, MD
Principal Investigator
Stanford Health Care
Pierre Henri Flurin, MD
Principal Investigator
Centre de l'Arthrose
Yann Marczuk, MD
Principal Investigator
Clinique Chenieux
Harry Brownlow, MD
Principal Investigator
Circle Health Group
Oliver Donaldson, MD
Principal Investigator
Yeovil District Hospital NHS Foundation
Chris Roberts, MD
Principal Investigator
Ipswich Hospital
Chris Peach, MD
Principal Investigator
University Hospital South Manchester
Angelo Di Giunta, MD
Principal Investigator
Policlinico Morgagni
Alfonso Romano, MD
Principal Investigator
Campolongo Hospital
Sean Grey, MD
Principal Investigator
Orthopaedic and Spine Center of the Rockies
Chad Manke, MD
Principal Investigator
Altantic Orthopaedics Specialists
Rick Papandrea, MD
Principal Investigator
Orthopaedic Associates of Wisconsin
Andrew Chambler, MD
Principal Investigator
The Sulis Hospital Bath
Curt Noel, MD
Principal Investigator
Crystal Clinic Orthopaedic
Stephen Parada, MD
Principal Investigator
Orthopedic and Sports Medicine
Ari Youderian, MD
Principal Investigator
South County Orthopedic Specialists
Ian Byram, MD
Principal Investigator
Bone and Joint Institute of Tennessee
Tewfik Benkalfate, MD
Principal Investigator
Clinique Mutualiste la Sagesse
Peter McCann, MD
Principal Investigator
Lenox Health Greenwich Village
Stephanie Muh, MD
Principal Investigator
Henry Ford Health
Bradley Schoch, MD
Principal Investigator
Mayo Clinic
Stephan Pill, MD
Principal Investigator
Steadman Hawkins Clinic of the Carolinas
Scott Trenhaile, MD
Principal Investigator
OrthoIllinois
Bryan Butler, MD
Principal Investigator
Orthopaedic Medical Group of Tampa Bay
Ben Gooding, MD
Principal Investigator
Nottingham City Hospital
Brad Carofino, MD
Principal Investigator
Altantic Orthopaedics Specialist
Ben Sears, MD
Principal Investigator
Western Orthopaedics
Kenneth Faber, MD
Principal Investigator
St Joseph's Health Care
Jaicharan Iyengar, MD
Principal Investigator
Alpine Orthopaedic Medical Group
Oke Anakwenze, MD
Principal Investigator
Duke Department of Orthopedic Surgery
Thomas Obermeyer, MD
Principal Investigator
Barrington Orthopedic
Alison Armstrong, MD
Principal Investigator
Leicester General Hospital
George Malal, MD
Principal Investigator
Bedford Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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