Actively Recruiting
INHANCE Stemless Reverse Shoulder IDE
Led by DePuy Orthopaedics · Updated on 2026-05-08
168
Participants Needed
19
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
CONDITIONS
Official Title
INHANCE Stemless Reverse Shoulder IDE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 information to DePuy Synthes.
- 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.
You will not qualify if you...
- Body mass index (BMI) greater than 40 kg/m2.
- Individuals with active, uncontrolled local infection or systemic infection.
- Patients who have not reached skeletal maturity, regardless of age.
- Bone stock in the proximal humerus or glenoid fossa is inadequate to support the INHANCE humeral stemless components.
- Bone quality is too soft, porous, hard, brittle, or affected by tumors, osteoporosis, or sclerotic bone to allow proper implant fixation.
- Fractures of the proximal humerus that could compromise fixation of the implant.
- Previous treatment on the study shoulder that may compromise fixation of the implant.
- Revision of a failed hemi, total, or reverse shoulder arthroplasty.
- Receiving or scheduled to receive treatments that could affect bone quality, such as chemotherapy or high dose corticosteroids.
- Individuals who are bedridden as determined by the Investigator.
- Participation in another clinical investigation with an investigational product in the last three months.
- Individuals involved in personal injury litigation, medical-legal, or worker's compensation claims.
- Drug or alcohol abuse or psychological disorders affecting ability to comply with questionnaires or follow-up.
- Known medical conditions impacting study outcomes, including osteomyelitis, Paget's disease, neuropathies, metastatic or neoplastic disorders.
- Medical condition with less than 2 years life expectancy.
- Known pregnancy or breastfeeding.
- Known polyethylene and/or metal sensitivity or allergy.
- Contralateral side enrolled in the study or had total shoulder operation within last 6 months.
- Medically unsuitable for participation as determined by the investigator.
- Member of a vulnerable population such as incarcerated individuals for at least one month.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Hoag Orthopedic Institute
Irvine, California, United States, 92618
Withdrawn
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
3
Orthopedic Center of Palm Beach County
Atlantis, Florida, United States, 33462
Actively Recruiting
4
Hospital for Special Surgery
West Palm Beach, Florida, United States, 33401
Not Yet Recruiting
5
Boston Bone & Joint Institute BBJI Formerly BSSC
Waltham, Massachusetts, United States, 02451
Actively Recruiting
6
Trinity Health Grand Rapids
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
7
Missouri Orthopaedic Institute (MOI)
Columbia, Missouri, United States, 65201
Actively Recruiting
8
OrthoCarolina Research Institute Charlotte
Charlotte, North Carolina, United States, 28207
Actively Recruiting
9
Duke Orthopaedics of Raleigh
Raleigh, North Carolina, United States, 27609
Actively Recruiting
10
Crystal Clinic Orthopaedic Center
Akron, Ohio, United States, 44333
Actively Recruiting
11
Lindner Research Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
12
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
Slocum Center for Orthopaedics and Sports Medicine
Eugene, Oregon, United States, 97401
Actively Recruiting
14
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
15
Rothman Orthopaedics Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
16
MTBJ a division of Tennessee Orthaepedic Alliance
Columbia, Tennessee, United States, 38401
Actively Recruiting
17
TOSH- The Orthopedic Specialty Hospital
Murray, Utah, United States, 84107
Withdrawn
18
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
19
Mary Washington Orthopedics in affiliation with FOA
Fredericksburg, Virginia, United States, 22408
Not Yet Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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