Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20000 participants
OBSERVATIONAL
2007-07-19
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
21 Years
ALL
No
Sponsors
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Exactech
INDUSTRY
Responsible Party
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Principal Investigators
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Alison Armstrong, MD
Role: PRINCIPAL_INVESTIGATOR
Leicester General Hospital
George Malal, MD
Role: PRINCIPAL_INVESTIGATOR
Bedford Hospital
Jonathan Wright, MD
Role: PRINCIPAL_INVESTIGATOR
UF Health Orthopaedics and Sports Medicine Institute
Young Kwon, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Joint Diseases - NYU Langone Health
Richard Friedman, MD
Role: PRINCIPAL_INVESTIGATOR
Charleston Orthopaedic Associates
Richard Jones, MD
Role: PRINCIPAL_INVESTIGATOR
Southeastern Orthopedics and Spine
Howard Routman, DO
Role: PRINCIPAL_INVESTIGATOR
Florida Atlantis Orthopaedics
Ryan Simovitch, MD
Role: PRINCIPAL_INVESTIGATOR
Palm Beach Orthopaedic Institute
Geoffrey Abrams, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford Health Care
Pierre Henri Flurin, MD
Role: PRINCIPAL_INVESTIGATOR
Centre de l'Arthrose
Yann Marczuk, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Chenieux
Harry Brownlow, MD
Role: PRINCIPAL_INVESTIGATOR
Circle Health Group
Oliver Donaldson, MD
Role: PRINCIPAL_INVESTIGATOR
Yeovil District Hospital NHS Foundation
Chris Roberts, MD
Role: PRINCIPAL_INVESTIGATOR
Ipswich Hospital
Chris Peach, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital South Manchester
Angelo Di Giunta, MD
Role: PRINCIPAL_INVESTIGATOR
Policlinico Morgagni
Alfonso Romano, MD
Role: PRINCIPAL_INVESTIGATOR
Campolongo Hospital
Sean Grey, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic and Spine Center of the Rockies
Chad Manke, MD
Role: PRINCIPAL_INVESTIGATOR
Altantic Orthopaedics Specialists
Rick Papandrea, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Associates of Wisconsin
Andrew Chambler, MD
Role: PRINCIPAL_INVESTIGATOR
The Sulis Hospital Bath
Curt Noel, MD
Role: PRINCIPAL_INVESTIGATOR
Crystal Clinic Orthopaedic
Stephen Parada, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopedic and Sports Medicine
Ari Youderian, MD
Role: PRINCIPAL_INVESTIGATOR
South County Orthopedic Specialists
Ian Byram, MD
Role: PRINCIPAL_INVESTIGATOR
Bone and Joint Institute of Tennessee
Tewfik Benkalfate, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Mutualiste la Sagesse
Peter McCann, MD
Role: PRINCIPAL_INVESTIGATOR
Lenox Health Greenwich Village
Stephanie Muh, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health
Bradley Schoch, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Stephan Pill, MD
Role: PRINCIPAL_INVESTIGATOR
Steadman Hawkins Clinic of the Carolinas
Scott Trenhaile, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoIllinois
Bryan Butler, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Medical Group of Tampa Bay
Ben Gooding, MD
Role: PRINCIPAL_INVESTIGATOR
Nottingham City Hospital
Brad Carofino, MD
Role: PRINCIPAL_INVESTIGATOR
Altantic Orthopaedics Specialist
Ben Sears, MD
Role: PRINCIPAL_INVESTIGATOR
Western Orthopaedics
Kenneth Faber, MD
Role: PRINCIPAL_INVESTIGATOR
St Joseph's Health Care
Jaicharan Iyengar, MD
Role: PRINCIPAL_INVESTIGATOR
Alpine Orthopaedic Medical Group
Oke Anakwenze, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Department of Orthopedic Surgery
Thomas Obermeyer, MD
Role: PRINCIPAL_INVESTIGATOR
Barrington Orthopedic
Locations
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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
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States
Bone and Joint Institute of Tenessee
Franklin, Tennessee, United States
Atlantic Orthopaedics Specialists
Virginia Beach, Virginia, United States
Orthopaedic Associates of Wisconsin
Pewaukee, Wisconsin, United States
St Joseph's Health Care
London, Ontario, Canada
Clinique Chenieux
Limoges, , France
Centre de l'arthrose
Mérignac, , France
Clinique Mutualiste La Sagesse
Rennes, , France
Policlinico Morgagni
Catania, , Italy
Campolongo Hospital
Eboli, , Italy
Circle Health Group
Reading, Berks, United Kingdom
Yeovil District Hospital NHS Foundation Trust
Yeovil, Summerset, United Kingdom
The Sulis Hospital Bath
Bath, , United Kingdom
Bedford Hospital
Bedford, , United Kingdom
Ipswich Hospital
Ipswich, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
University Hospital South Manchester
Manchester, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Anna Ramakrishnan
Role: primary
Libby Mauter
Role: primary
Josh Orr
Role: primary
Aimee Struk
Role: primary
Jennnifer Wirtz
Role: primary
Meg Ryan
Role: primary
Rachel Routman
Role: primary
Kendra Richerdson
Role: primary
Elizabeth Barker
Role: primary
Timothy Nelligan
Role: primary
Johnny Kasto
Role: primary
Role: primary
Johnathan Joseph
Role: primary
Rebecca Rathbone
Role: primary
Ginny Texter
Role: primary
Lisa Mock
Role: primary
Kyle Adams
Role: primary
Kristin Freeman
Role: primary
Brice Snyder
Role: primary
Ryann Hamm
Role: primary
Estelle Tillet
Role: primary
Diane Deplanque
Role: primary
Tewfik Benkalfate
Role: primary
Gionacchino Zappulla
Role: primary
Francesco Ascione
Role: primary
Richard Forbes
Role: primary
Oliver Donaldson
Role: primary
Darren James
Role: primary
David B Smith
Role: primary
Rebecca Carter
Role: primary
Donna King
Role: primary
Other Identifiers
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CR09-005
Identifier Type: -
Identifier Source: org_study_id
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