Arthroplasty, Replacement, Shoulder
Conditions
Keywords
Reverse Shoulder, Stemless Shoulder, Total Shoulder
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.
Interventions
DEVICEReverse Total Shoulder
Uncemented Reverse Total Shoulder
Sponsors
DePuy Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2:1 Randomized (Stemless to Stemmed)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant Murley Score (CMS) | Pre-op, 3-month, 6-month, 1 year, 2 year | Adjusted Constant-Murley Score at baseline and 3- and 6-months and 1- and 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. |
| EQ-5D-5L and EQ-VAS | Pre-op, 3-month, 6-month, 1 year, 2 year | EQ-5D-5L Scores by dimension and EQ-VAS, at baseline and 3- and 6-months and 1- and 2-years post-operative. The value score generally ranges from less than 0 to 1, with higher scores indicating higher health utility. The EQ VAS records the subject's self-rated health from 0 (worst) to 100 (best). |
| Simple Shoulder Test | Pre-op, 3-month, 6-month, 1 year, 2 year | Simple Shoulder Test (SST) Scores at baseline and 3- and 6-months and 1- and 2-years post-operative. Scores range from 0 (worst) to 12 (best). |
| Single Assessment Numeric Evaluation (SANE) Score | Pre-op, 3-month, 6-month, 1 year, 2 year | Single Assessment Numeric Evaluation (SANE) Scores at baseline and 3- and 6-months and 1- and 2-years post-operative. The scale is 0 to 100 with 100 being "normal". |
| Survivorship | 2 year | Overall survivorship of the INHANCE Shoulder System at 2 years post-operative, where the system is deemed to be surviving if no components (humeral stem or stemless component, glenosphere, baseplate, liner, etc.) have been removed for any reason, will be presented using the Kaplan-Meier method. |
| Complications | 2 year | The type and frequency of all reportable adverse events (AEs) and device deficiencies in this study will be summarized, with distinction of serious AEs, device and procedure related AEs |
Countries
United States
Contacts
CONTACTStudy Contact
Outcome results
None listed