INHANCE Stemless Reverse Shoulder IDE

Arthroplasty Clinical Trial

Official title:

Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06323980
• Other study ID #: DSM202108
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2024
• Est. completion date: April 27, 2028

Study information

• Verified date: June 2024
• Source: DePuy Orthopaedics
• Contact: Study Contact
• Phone: 574-404-7996
• Email: dfawley1[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: April 27, 2028
• Est. primary completion date: November 10, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthroplasty
• Replacement
• Shoulder

Intervention

Device:
• Reverse Total Shoulder
Uncemented Reverse Total Shoulder

Locations

Country	Name	City	State
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	OrthoCarolina Research Institute Charlotte	Charlotte	North Carolina
United States	Lindner Research Center	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Missouri Orthopaedic Institute (MOI)	Columbia	Missouri
United States	MTBJ a division of Tennessee Orthaepedic Alliance	Columbia	Tennessee
United States	Slocum Center for Orthpaedics and Sports Medicine	Eugene	Oregon
United States	Trinity Health Grand Rapids	Grand Rapids	Michigan
United States	Hoag Orthopedic Institute	Irvine	California
United States	Atlantis Orthopaedics	Lake Worth	Florida
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	TOSH- The Orthopedic Specialty Hospital	Murray	Utah
United States	Rothman Orthopaedics Institute	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	Boston Sports & Shoulder Center	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Constant Murley Score (CMS)	Change from baseline adjusted Constant-Murley Score at 3- and 6-months and 1- year 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.	Pre-op, 3-month, 6-month, 1 year
Other	EQ-5D-5L and EQ-VAS	Change from baseline EQ-5D-5L Value Score and EQ-VAS, at 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).	Pre-op, 3-month, 6-month, 1 year, 2 year
Other	Simple Shoulder Test	Change from baseline SST Scores at 3- and 6-months and 1- and 2-years post-operative. Scores range from 0 (worst) to 12 (best).	Pre-op, 3-month, 6-month, 1 year, 2 year
Other	Single Assessment Numeric Evaluation (SANE) Score	Change from baseline SANE Scores at 3- and 6-months and 1- and 2-years post-operative. The scale is 0 to 100 with 100 being "normal".	Pre-op, 3-month, 6-month, 1 year, 2 year
Other	Range of Motion	Change from baseline range of motion at 3- and 6-months and 1- and 2-years post-operative	Pre-op, 3-month, 6-month, 1 year, 2 year
Primary	Constant Murley Score (CMS)	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.	Pre-op, 2 years
Primary	Removal of any system component	No removal of any system component	2 year
Primary	Revision of any system component	No revision of any system component	2 year
Primary	Reoperation of any system component	No reoperation of any system component	2 year
Primary	Supplemental Fixation of any system component	No supplemental fixation of any system component	2 year
Primary	Radiolucent Lines (Humeral & Glenoid)	No humeral or glenoid radiolucent line greater than 2mm is present in 50% or more zones	2 year
Primary	Migration and Tilt (Humeral & Glenoid)	No conclusive evidence of migration and tilt (greater than 5mm migration and greater than 10 degrees tilt) of the humeral or glenoid component	2 year
Secondary	Constant Murley Score (CMS)	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.	Pre-op, 3-month, 6-month, 1 year, 2 year
Secondary	EQ-5D-5L and EQ-VAS	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).	Pre-op, 3-month, 6-month, 1 year, 2 year
Secondary	Simple Shoulder Test	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).	Pre-op, 3-month, 6-month, 1 year, 2 year
Secondary	Single Assessment Numeric Evaluation (SANE) Score	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".	Pre-op, 3-month, 6-month, 1 year, 2 year
Secondary	Survivorship	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.	2 year
Secondary	Complications	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	2 year