Actively Recruiting
Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
Led by DePuy Orthopaedics · Updated on 2026-06-05
168
Participants Needed
19
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, controlled, multi-center study to evaluate the INHANCE Stemless Reverse Cementless Total Shoulder system. This study compares this stemless shoulder replacement device to a traditional stemmed reverse shoulder system in individuals needing reverse total shoulder replacement due to severe pain and disabling arthritis. The goal is to assess both the effectiveness and safety of the stemless system over a two-year period. Participants will be randomly assigned in a 2:1 ratio to receive either the INHANCE Stemless Reverse Total Shoulder or the INHANCE Stemmed Reverse Total Shoulder device. The study includes follow-up visits at multiple time points including pre-operation, 3 months, 6 months, 1 year, and 2 years to monitor outcomes. The primary focus is on changes in shoulder function measured by the Constant-Murley Score and safety endpoints such as absence of device revision, radiolucent lines, and component migration or tilt after two years. During the study, participants will undergo evaluations including physical assessments, patient-reported outcome questionnaires, and imaging to monitor implant stability. Researchers will track complications, shoulder function, and quality of life using various tools such as the Constant Murley Score, EQ-5D-5L, Simple Shoulder Test, and SANE Score. The total duration of participation spans at least two years, during which safety and effectiveness data will be collected to determine the performance of the implant systems.
CONDITIONS
Brief 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 such as osteoarthritis, post-traumatic arthritis, or rotator cuff arthropathy
- Individuals anatomically and structurally suited to receive the implants with a functional deltoid muscle
- Individuals able to read, understand, and provide informed consent and authorize transfer of their information
- Individuals willing and able to return for follow-up visits as specified by the study protocol
- Individuals aged 22 years or older at the time of consent
- Individuals willing and able to complete the Patient Reported Outcome Measure questionnaires as specified by the study protocol
You will not qualify if you...
- Body mass index (BMI) over 40 kg/m2
- Active, uncontrolled local or systemic infection
- Patients who have not reached skeletal maturity
- Inadequate bone stock in proximal humerus or glenoid fossa for implant support
- Bone quality too soft, porous, hard, brittle, or affected by tumors compromising implant fixation
- Fractures of proximal humerus that compromise implant fixation
- Previous treatment on the study shoulder compromising implant fixation
- Revision of failed hemi, total, or reverse shoulder arthroplasty
- Receiving or scheduled for treatments affecting bone quality such as chemotherapy or high dose corticosteroids
- Bedridden individuals as determined by the investigator
- Participation in another clinical investigation with investigational product within last three months
- Current involvement in personal injury litigation, medical-legal, or worker's compensation claims
- Drug or alcohol abuse or psychological disorders impacting compliance or questionnaire completion
- Known medical conditions impacting study outcomes such as osteomyelitis, Paget's disease, neuropathies, metastatic or neoplastic disorders
- Medical condition with less than 2 years life expectancy
- Known pregnancy or breastfeeding
- Known polyethylene or metal sensitivity or allergy
- Contralateral shoulder enrolled in study or operated within last 6 months
- Medically unsuitable as determined by investigator
- Member of vulnerable population such as incarcerated individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants receive the reverse total shoulder replacement surgery and immediate post-operative care.
1 surgical visit and initial post-operative visits
Duration - 2 years
Participants attend follow-up visits to monitor recovery and assess shoulder function and safety.
Visits at 3 months, 6 months, 1 year, and 2 years post-surgery
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
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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