Clinical trial NCT06323980: INHANCE Stemless Reverse Shoulder IDE
Official title: Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty
Replacement
Shoulder
Keywords: Reverse Shoulder
Stemless Shoulder
Total Shoulder
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2024-03-21
Enrollment: 168
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 Randomized (Stemless to Stemmed)
Primary purpose: TREATMENT

Brief summary: 2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.

Detailed description: There is one primary effectiveness endpoint and there are three primary safety endpoints:

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.

Eligibility criteria: 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 outcomes:
measure: Constant Murley Score (CMS)
timeFrame: Pre-op, 2 years
measure: Removal of any system component
timeFrame: 2 year
measure: Revision of any system component
timeFrame: 2 year
measure: Reoperation of any system component
timeFrame: 2 year
measure: Supplemental Fixation of any system component
timeFrame: 2 year
measure: Radiolucent Lines (Humeral & Glenoid)
timeFrame: 2 year
measure: Migration and Tilt (Humeral & Glenoid)
timeFrame: 2 year
Secondary outcomes:
measure: Constant Murley Score (CMS)
timeFrame: Pre-op, 3-month, 6-month, 1 year, 2 year
measure: EQ-5D-5L and EQ-VAS
timeFrame: Pre-op, 3-month, 6-month, 1 year, 2 year
measure: Simple Shoulder Test
timeFrame: Pre-op, 3-month, 6-month, 1 year, 2 year
measure: Single Assessment Numeric Evaluation (SANE) Score
timeFrame: Pre-op, 3-month, 6-month, 1 year, 2 year
measure: Survivorship
timeFrame: 2 year
measure: Complications
timeFrame: 2 year
Other outcomes:
measure: Constant Murley Score (CMS)
timeFrame: Pre-op, 3-month, 6-month, 1 year
measure: EQ-5D-5L and EQ-VAS
timeFrame: Pre-op, 3-month, 6-month, 1 year, 2 year
measure: Simple Shoulder Test
timeFrame: Pre-op, 3-month, 6-month, 1 year, 2 year
measure: Single Assessment Numeric Evaluation (SANE) Score
timeFrame: Pre-op, 3-month, 6-month, 1 year, 2 year
measure: Range of Motion
timeFrame: Pre-op, 3-month, 6-month, 1 year, 2 year
Locations:
city: Irvine
country: United States
facility: Hoag Orthopedic Institute
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Atlantis
country: United States
facility: Orthopedic Center of Palm Beach County
state: Florida
city: Waltham
country: United States
facility: Boston Sports & Shoulder Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Trinity Health Grand Rapids
state: Michigan
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute (MOI)
state: Missouri
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute Charlotte
state: North Carolina
city: Raleigh
country: United States
facility: Duke Orthopaedics of Raleigh
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Research Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Eugene
country: United States
facility: Slocum Center for Orthopaedics and Sports Medicine
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Orthopaedics Institute
state: Pennsylvania
city: Columbia
country: United States
facility: MTBJ a division of Tennessee Orthaepedic Alliance
state: Tennessee
city: Murray
country: United States
facility: TOSH- The Orthopedic Specialty Hospital
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: