Osteoarthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 18 years of age or older and have reached full bone maturity
• People who are scheduled for their first (not repeat) planned shoulder replacement surgery — either a standard (anatomic) or reverse type
• The shoulder replacement must be for one of these reasons: rheumatoid arthritis, arthritis caused by a past injury, general wear-and-tear joint disease (non-inflammatory), or to correct a physical deformity of the shoulder
• People who are willing and able to attend all required study visits and follow the recommended recovery and therapy program after surgery
• People who live in a stable location and are able to return to the study site for all follow-up appointments
• People who have been fully informed about the study requirements and risks, and are willing to provide written consent to participate

Who may not be able to join:

• People for whom the AETOS implant (the device being studied) is not medically suitable (confirm with trial site)
• People who are having a revision (repeat) shoulder replacement surgery, either full or partial
• People whose surgery plan involves replacing only one part of the shoulder joint (hemiarthroplasty)
• People who have a traumatic injury or a bone fracture in the affected area
• People with poorly controlled diabetes, indicated by a blood sugar marker (HbA1c) of 7.5 or higher
• People with other health conditions that could prevent the implant from healing or attaching properly
• People whose bone is too thin, weak, or insufficient to properly support the implant
• People whose bone quality is so poor that the implant could shift position or cause a fracture
• People with rapid bone loss or severe bone thinning (such as severe osteoporosis)
• People who have a bone-softening condition called osteomalacia
• People with muscle, nerve, or blood vessel problems that could affect the outcome of the surgery
• People with a known allergy or sensitivity to any of the materials used in the implant
• People with an active infection anywhere in the body, or a bone infection, that could potentially spread to the implant site
• People with unexplained abnormal blood test results that may indicate infection or inflammation (confirm with trial site)
• For reverse shoulder replacement candidates only: people whose deltoid muscle or external shoulder rotation muscles do not function
• For reverse shoulder replacement candidates only: people with a significant injury to the upper part of the brachial plexus (a network of nerves in the shoulder area)
• For reverse shoulder replacement candidates only: people with paralysis of the axillary nerve (a key nerve in the shoulder)
• People who are unable to follow instructions, have a neurological condition affecting their ability to understand and cooperate, or whose ability to make a fully informed, independent decision may be compromised
• People who are pregnant or planning to become pregnant during the study follow-up period
• People with a Body Mass Index (BMI) over 35 kg/m², or a BMI level that the treating doctor considers likely to affect the outcome of the surgery
• People whose planned activities would place very high physical stress on the implant, or who are considered at high risk of falling
• People who have smoked, vaped, or misused alcohol or drugs within the 180 days before giving consent
• People who previously joined this same clinical trial but were withdrawn
• People who are currently taking part in another clinical trial involving a medical device, drug, or competing observational study

Important: Always verify eligibility with the trial site directly before applying.