Exactech Shoulder Post Market Clinical Follow-up Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05603728
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Exactech
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jonathan Wright, MDYoung Kwon, MDRichard Friedman, MDRichard Jones, MDHoward Routman, DORyan Simovitch, MDGeoffrey Abrams, MDPierre Henri Flurin, MDYann Marczuk, MDHarry Brownlow, MDOliver Donaldson, MDChris Roberts, MDChris Peach, MDAngelo Di Giunta, MDAlfonso Romano, MDSean Grey, MDChad Manke, MDRick Papandrea, MDAndrew Chambler, MDCurt Noel, MDStephen Parada, MDAri Youderian, MDIan Byram, MDTewfik Benkalfate, MDPeter McCann, MDStephanie Muh, MDBradley Schoch, MDStephan Pill, MDScott Trenhaile, MDBryan Butler, MDBen Gooding, MDBrad Carofino, MDBen Sears, MDKenneth Faber, MDJaicharan Iyengar, MDOke Anakwenze, MDThomas Obermeyer, MDAlison Armstrong, MDGeorge Malal, MD
Principal Investigator Affiliation	UF Health Orthopaedics and Sports Medicine InstituteHospital for Joint Diseases - NYU Langone HealthCharleston Orthopaedic AssociatesSoutheastern Orthopedics and SpineFlorida Atlantis OrthopaedicsPalm Beach Orthopaedic InstituteStanford Health CareCentre de l'ArthroseClinique ChenieuxCircle Health GroupYeovil District Hospital NHS FoundationIpswich HospitalUniversity Hospital South ManchesterPoliclinico MorgagniCampolongo HospitalOrthopaedic and Spine Center of the RockiesAltantic Orthopaedics SpecialistsOrthopaedic Associates of WisconsinThe Sulis Hospital BathCrystal Clinic OrthopaedicOrthopedic and Sports MedicineSouth County Orthopedic SpecialistsBone and Joint Institute of TennesseeClinique Mutualiste la SagesseLenox Health Greenwich VillageHenry Ford HealthMayo ClinicSteadman Hawkins Clinic of the CarolinasOrthoIllinoisOrthopaedic Medical Group of Tampa BayNottingham City HospitalAltantic Orthopaedics SpecialistWestern OrthopaedicsSt Joseph's Health CareAlpine Orthopaedic Medical GroupDuke Department of Orthopedic SurgeryBarrington OrthopedicLeicester General HospitalBedford Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, France, Italy, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Ankylosing Spondylitis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis, Fracture, Infections

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

South County Orthopedic Specialists, Laguna Woods 5364369, California 5332921

Status

Recruiting

Address

South County Orthopedic Specialists

Laguna Woods 5364369, California 5332921, 92637

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