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
Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Constant — Through study completion, an average of 1 per year Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain
ASES — Through study completion, an average of 1 per year American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition
Oxford Score (may be used as an optional form for surgeons in the United Kingdom) — Through study completion, an average of 1 per year Oxford Shoulder Score (OSS) - 12 questions assessing outcomes of shoulder surgery and its impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems - Maximum score is 60 and indicates greater degree of disability
TESS (may be used as specific forms related to the pre-operative condition/diagnosis) — Through study completion, an average of 1 per year Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome
MSTS (may be used as specific forms related to the pre-operative condition/diagnosis) — Through study completion, an average of 1 per year Musculoskeletal Tumor Society (MSTS) - 30 points \[6 times (range 0-5)\], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score
Trial sites (40)
Facility
City
Region
Status
South County Orthopedic Specialists
Laguna Woods
California
Recruiting
Stanford Health Care
Redwood City
California
Recruiting
Alpine Orthopaedic Medical Group
Stockton
California
Recruiting
Western Orthopaedics
Denver
Colorado
Recruiting
Orthopaedic and Spine Center of the Rockies
Fort Collins
Colorado
Recruiting
UF Health Orthopaedics and Sports Medicine Institute
Gainesville
Florida
Recruiting
Mayo Clinic
Jacksonville
Florida
Recruiting
Florida Atlantis Orthopedics
Palm Beach Gardens
Florida
Recruiting
Orthopaedic Medical Group of Tampa Bay
Tampa
Florida
Recruiting
HSS Florida
West Palm Beach
Florida
Recruiting
Orthopedic and Sports Medicine
Augusta
Georgia
Recruiting
OrthoIllinois
Rockford
Illinois
Recruiting
Barrington Orthpedic Specialists
Schaumburg
Illinois
Recruiting
Henry Ford Health
Detroit
Michigan
Recruiting
Hospital for Joint Diseases - NYU Langone Health
New York
New York
Recruiting
Lenox Health Greenwich Village
New York
New York
Recruiting
Southeastern Sports Medicine and Orthopedics
Asheville
North Carolina
Recruiting
Duke Department of Orthopedic Surgery
Durham
North Carolina
Recruiting
Crystal Clinic Orthopaedic
Akron
Ohio
Recruiting
Charleston Orthopaedic Associates
Charleston
South Carolina
Recruiting
Steadman Hawkins Clinic of the Carolinas
Greenville
South Carolina
Recruiting
Bone and Joint Institute of Tenessee
Franklin
Tennessee
Recruiting
Atlantic Orthopaedics Specialists
Virginia Beach
Virginia
Recruiting
Orthopaedic Associates of Wisconsin
Pewaukee
Wisconsin
Recruiting
St Joseph's Health Care
London
Ontario
Recruiting
Clinique Belledone
Grenoble
France
Recruiting
Centre de l'arthrose
Mérignac
France
Recruiting
Clinique Mutualiste La Sagesse
Rennes
France
Recruiting
Malteser Waldkrankenhaus Erlangen
Erlangen
Germany
Recruiting
Orthopadische Praxisklinik Von Vincke
Münster
Germany
Recruiting
Policlinico Morgagni
Catania
Italy
Recruiting
Campolongo Hospital
Eboli
Italy
Recruiting
Circle Health Group
Reading
Berks
Recruiting
Yeovil District Hospital NHS Foundation Trust
Yeovil
Summerset
Recruiting
The Sulis Hospital Bath
Bath
United Kingdom
Recruiting
Bedford Hospital
Bedford
United Kingdom
Recruiting
Ipswich Hospital
Ipswich
United Kingdom
Recruiting
Leicester General Hospital
Leicester
United Kingdom
Recruiting
University Hospital South Manchester
Manchester
United Kingdom
Recruiting
Nottingham University Hospital
Nottingham
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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