Ankylosing Spondylitis, Fracture, Infections, Osteo Arthritis Shoulders, Osteonecrosis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis, Rotator Cuff Tear Arthropathy, Rotator Cuff Tears
Conditions
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. 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.
Interventions
None listed
Sponsors
Exactech
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, France, Germany, Italy, United Kingdom, United States
Contacts
CONTACTRachael Craig
CONTACTSandrine Angibaud
PRINCIPAL_INVESTIGATORJonathan Wright, MD
UF Health Orthopaedics and Sports Medicine Institute
PRINCIPAL_INVESTIGATORYoung Kwon, MD
Hospital for Joint Diseases - NYU Langone Health
PRINCIPAL_INVESTIGATORRichard Friedman, MD
Charleston Orthopaedic Associates
PRINCIPAL_INVESTIGATORRichard Jones, MD
Southeastern Orthopedics and Spine
PRINCIPAL_INVESTIGATORHoward Routman, DO
Florida Atlantis Orthopaedics
PRINCIPAL_INVESTIGATORRyan Simovitch, MD
HSS
PRINCIPAL_INVESTIGATORGeoffrey Abrams, MD
Stanford Health Care
PRINCIPAL_INVESTIGATORPierre Henri Flurin, MD
Centre de l'Arthrose
PRINCIPAL_INVESTIGATORHarry Brownlow, MD
Circle Health Group
PRINCIPAL_INVESTIGATOROliver Donaldson, MD
Yeovil District Hospital NHS Foundation
PRINCIPAL_INVESTIGATORChris Roberts, MD
Ipswich Hospital
PRINCIPAL_INVESTIGATORChris Peach, MD
University Hospital South Manchester
PRINCIPAL_INVESTIGATORAngelo Di Giunta, MD
Policlinico Morgagni
PRINCIPAL_INVESTIGATORAlfonso Romano, MD
Campolongo Hospital
PRINCIPAL_INVESTIGATORSean Grey, MD
Orthopaedic and Spine Center of the Rockies
PRINCIPAL_INVESTIGATORChad Manke, MD
Altantic Orthopaedics Specialists
PRINCIPAL_INVESTIGATORRick Papandrea, MD
Orthopaedic Associates of Wisconsin
PRINCIPAL_INVESTIGATORAndrew Chambler, MD
The Sulis Hospital Bath
PRINCIPAL_INVESTIGATORCurt Noel, MD
Crystal Clinic Orthopaedic
PRINCIPAL_INVESTIGATORStephen Parada, MD
Orthopedic and Sports Medicine
PRINCIPAL_INVESTIGATORAri Youderian, MD
South County Orthopedic Specialists
PRINCIPAL_INVESTIGATORIan Byram, MD
Bone and Joint Institute of Tennessee
PRINCIPAL_INVESTIGATORTewfik Benkalfate, MD
Clinique Mutualiste la Sagesse
PRINCIPAL_INVESTIGATORPeter McCann, MD
Lenox Health Greenwich Village
PRINCIPAL_INVESTIGATORJared Mahylis, MD
Henry Ford Health
PRINCIPAL_INVESTIGATORBradley Schoch, MD
Mayo Clinic
PRINCIPAL_INVESTIGATORStephan Pill, MD
Steadman Hawkins Clinic of the Carolinas
PRINCIPAL_INVESTIGATORScott Trenhaile, MD
OrthoIllinois
PRINCIPAL_INVESTIGATORBryan Butler, MD
Orthopaedic Medical Group of Tampa Bay
PRINCIPAL_INVESTIGATORBen Gooding, MD
Nottingham City Hospital
PRINCIPAL_INVESTIGATORBrad Carofino, MD
Altantic Orthopaedics Specialist
PRINCIPAL_INVESTIGATORBen Sears, MD
Western Orthopaedics
PRINCIPAL_INVESTIGATORKenneth Faber, MD
St Joseph's Health Care
PRINCIPAL_INVESTIGATORJaicharan Iyengar, MD
Alpine Orthopaedic Medical Group
PRINCIPAL_INVESTIGATOROke Anakwenze, MD
Duke Department of Orthopedic Surgery
PRINCIPAL_INVESTIGATORThomas Obermeyer, MD
Barrington Orthopedic
PRINCIPAL_INVESTIGATORAlison Armstrong, MD
Leicester General Hospital
PRINCIPAL_INVESTIGATORGeorge Malal, MD
Bedford Hospital
PRINCIPAL_INVESTIGATORDiego Lima, MD
Florida Atlantis Orthopaedics
PRINCIPAL_INVESTIGATORRemi Charvet, MD
Clinique Belledone
PRINCIPAL_INVESTIGATORJorn Steinbeck, MD
Orthopadische Praxisklinik Von Vincke
PRINCIPAL_INVESTIGATORThomas Tischer, MD
Malteser Waldkrankenhaus Erlangen
Outcome results
None listed