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New treatment option for Arthroplasty
Official title INHANCE Stemless Reverse Shoulder IDE
ClinicalTrials.gov ID: NCT06323980
What this study is testing
- What it's testing
- 2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic...
- Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle.
- Individuals who are able to read and comprehend the informed patient consent document and are willing and able to provide informed patient consent...
- Individuals who are willing and able to return for follow-up as specified by the study protocol.
- Individuals who are a minimum age of 22 years at the time of consent.
You likely can't join if
- BMI \> 40 kg/m2
- Individuals have active, uncontrolled local infection or systemic infection.
- Patients who have not reached skeletal maturity, regardless of age.
- Either preoperatively or intraoperatively and per standard of care medical assessment, bone stock in the proximal humerus or glenoid fossa is...
- Intraoperatively and per treating physician's assessment of bone quality, bone is determined to be too soft or porous to support the implant or that...
- Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components.
See the full eligibility criteria
- Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy).
- Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle.
- Individuals who are able to read and comprehend the informed patient consent document and are willing and able to provide informed patient consent for participation in the study and have authorized the transfer of their...
- Individuals who are willing and able to return for follow-up as specified by the study protocol.
- Individuals who are a minimum age of 22 years at the time of consent.
- Individuals who are willing and able to complete the Patient Reported Outcome Measure questionnaires (PROMs) as specified by the study protocol.
- BMI \> 40 kg/m2
- Individuals have active, uncontrolled local infection or systemic infection.
- Patients who have not reached skeletal maturity, regardless of age.
- Either preoperatively or intraoperatively and per standard of care medical assessment, bone stock in the proximal humerus or glenoid fossa is determined to be inadequate for supporting the INHANCE humeral stemless...
- Intraoperatively and per treating physician's assessment of bone quality, bone is determined to be too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and...
- Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components.
- Patients who have undergone previous treatment on the study shoulder that may compromise fixation of the INHANCE reverse humeral stemless component.
- Revision of a failed hemi, total or reverse shoulder arthroplasty.
- Patient is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids.
- Individuals who are bedridden per the Investigator's determination.
- Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
- Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete patient reported questionnaires or be compliant with follow-up...
- Patients with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or...
- Patient has a medical condition with less than 2 years life expectancy.
- Patients who are known to be pregnant or breastfeeding.
- Known polyethylene and/or metal sensitivity or allergy.
- Contralateral side has been enrolled in the study or has received a total shoulder operation within the last 6 months
- Otherwise determined by the investigator to be medically unsuitable for participation in this study
- Patient is a member of a vulnerable population (i.e., incarcerated individuals - those incarcerated for at least one month and considered to be an inmate)
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Los Angeles, California, United States
- Atlantis, Florida, United States
- West Palm Beach, Florida, United States
- Waltham, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Columbia, Missouri, United States
- Charlotte, North Carolina, United States
- Raleigh, North Carolina, United States
- Akron, Ohio, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Eugene, Oregon, United States
- Bethlehem, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Columbia, Tennessee, United States
- Murray, Utah, United States
- Salt Lake City, Utah, United States
- Fredericksburg, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Los Angeles, California, United States; Atlantis, Florida, United States; West Palm Beach, Florida, United States; Waltham, Massachusetts, United States; Grand Rapids, Michigan, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.