Reverse Total Shoulder: Uncemented Reverse Total Shoulder
Study summary
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Individuals requiring reverse total shoulder replacement for a severely painful, disabling, arthritic joint (i.e. osteoarthritis, post-traumatic arthritis and rotator cuff arthropathy).
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:
1. BMI \> 40 kg/m2
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)
Primary outcome measure(s)
Constant Murley Score (CMS) — Pre-op, 2 years Primary effectiveness endpoint - Adjusted Constant-Murley Change from Baseline (ACM CFB) at 2 years post-operative. The CMS is a 100 point scale, the higher the score, the higher the quality of the function. ACM will be obtained by dividing the raw score by the relative score.
Removal of any system component — 2 year No removal of any system component
Revision of any system component — 2 year No revision of any system component
Reoperation of any system component — 2 year No reoperation of any system component
Supplemental Fixation of any system component — 2 year No supplemental fixation of any system component
Radiolucent Lines (Humeral & Glenoid) — 2 year No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones
Migration and Tilt (Humeral & Glenoid) — 2 year No conclusive evidence of migration and tilt (greater than 5mm migration and greater than 10 degrees tilt) of the humeral or glenoid component
Trial sites (15)
Facility
City
Region
Status
Orthopedic Center of Palm Beach County
Atlantis
Florida
Recruiting
Boston Bone & Joint Institute BBJI Formerly BSSC
Waltham
Massachusetts
Recruiting
Trinity Health Grand Rapids
Grand Rapids
Michigan
Recruiting
Missouri Orthopaedic Institute (MOI)
Columbia
Missouri
Recruiting
OrthoCarolina Research Institute Charlotte
Charlotte
North Carolina
Recruiting
Duke Orthopaedics of Raleigh
Raleigh
North Carolina
Recruiting
Crystal Clinic Orthopaedic Center
Akron
Ohio
Recruiting
Lindner Research Center
Cincinnati
Ohio
Recruiting
The Cleveland Clinic Foundation
Cleveland
Ohio
Recruiting
Slocum Center for Orthopaedics and Sports Medicine
Eugene
Oregon
Recruiting
St. Luke's University Health Network
Bethlehem
Pennsylvania
Recruiting
Rothman Orthopaedics Institute
Philadelphia
Pennsylvania
Recruiting
MTBJ a division of Tennessee Orthaepedic Alliance
Columbia
Tennessee
Recruiting
University of Utah
Salt Lake City
Utah
Recruiting
Mary Washington Orthopedics in affiliation with FOA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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