Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
168 participants
INTERVENTIONAL
2025-03-04
2028-09-29
Brief Summary
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Detailed Description
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1. Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative
2. Primary safety endpoint(s):
1. No revision, removal, reoperation, supplemental fixation, or other intervention for any system component
2. No humeral or glenoid radiolucent line \>2 mm is present in 50% or more zones at 2 years
3. No conclusive evidence of migration and tilt (\>5mm migration and \>10° tilt) of the humeral or glenoid component at 2 years
The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated, and no significant difference is seen on any of the 3 primary safety endpoints.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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INHANCE Stemless Reverse
INHANCE(TM) Stemless Reverse Total Shoulder
Reverse Total Shoulder
Uncemented Reverse Total Shoulder
INHANCE Stemmed Reverse
INHANCE(TM) Stemmed Reverse Total Shoulder
Reverse Total Shoulder
Uncemented Reverse Total Shoulder
Interventions
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Reverse Total Shoulder
Uncemented Reverse Total Shoulder
Eligibility Criteria
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Inclusion Criteria
2. Individuals who are anatomically and structurally suited to receive the implants and have a functional deltoid muscle.
3. 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 information to DePuy Synthes.
4. Individuals who are willing and able to return for follow-up as specified by the study protocol.
5. Individuals who are a minimum age of 22 years at the time of consent.
6. Individuals who are willing and able to complete the Patient Reported Outcome Measure questionnaires (PROMs) as specified by the study protocol.
Exclusion Criteria
2. Individuals have active, uncontrolled local infection or systemic infection.
3. Patients who have not reached skeletal maturity, regardless of age.
4. 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 components (NOTE: exclusion applies to both arms of the study, i.e., bone stock to be evaluated independent of randomized treatment assignment).
5. 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 fixation, i.e. osteoporosis or sclerotic bone, or tumor(s) of the supporting bone structure, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid.
6. Fractures of the proximal humerus that could compromise the fixation of the INHANCE reverse humeral stemless components.
7. Patients who have undergone previous treatment on the study shoulder that may compromise fixation of the INHANCE reverse humeral stemless component.
8. Revision of a failed hemi, total or reverse shoulder arthroplasty.
9. Patient is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids.
10. Individuals who are bedridden per the Investigator's determination.
11. Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months.
12. Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
13. 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 requirements.
14. 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 neoplastic disorders).
15. Patient has a medical condition with less than 2 years life expectancy.
16. Patients who are known to be pregnant or breastfeeding.
17. Known polyethylene and/or metal sensitivity or allergy.
18. Contralateral side has been enrolled in the study or has received a total shoulder operation within the last 6 months
19. Otherwise determined by the investigator to be medically unsuitable for participation in this study
20. 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)
22 Years
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Locations
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Hoag Orthopedic Institute
Irvine, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Orthopedic Center of Palm Beach County
Atlantis, Florida, United States
Boston Sports & Shoulder Center
Waltham, Massachusetts, United States
Trinity Health Grand Rapids
Grand Rapids, Michigan, United States
Missouri Orthopaedic Institute (MOI)
Columbia, Missouri, United States
OrthoCarolina Research Institute Charlotte
Charlotte, North Carolina, United States
Duke Orthopaedics of Raleigh
Raleigh, North Carolina, United States
Crystal Clinic Orthopaedic Center
Akron, Ohio, United States
Lindner Research Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Slocum Center for Orthopaedics and Sports Medicine
Eugene, Oregon, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Rothman Orthopaedics Institute
Philadelphia, Pennsylvania, United States
MTBJ a division of Tennessee Orthaepedic Alliance
Columbia, Tennessee, United States
TOSH- The Orthopedic Specialty Hospital
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Other Identifiers
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DSM202108
Identifier Type: OTHER
Identifier Source: secondary_id
DSM202108
Identifier Type: -
Identifier Source: org_study_id