Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

Study Purpose

The goal of this study is to compare the effect of different ways to place the component that goes at the top of the humerus (upper arm) in reverse total shoulder replacement. Some surgeons place the humeral tray component sitting on the bone while others place it in the bone. Changing the way that the humeral component is placed may change how much the arm can raise up or turn out/in after surgery for some patients. This study compares patients with inlay humeral component (tray sits in the upper arm bone) versus onlay humeral component (tray sits on top of the upper arm bone) to see if there are differences in range of motion or function after surgery.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients undergoing primary reverse total shoulder arthroplasty with the following components: 1.

Onlay group: Ascend Flex stem, Perform Reversed standard +3 lateralized 25mm baseplate with standard 36 mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere. 2. Inlay group: Perform Stem Reverse, Perform Reversed +3 lateralized 25mm baseplate with standard 36mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere.

- Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear.

- Negative external rotation lag sign, ability to externally rotate beyond neutral.

- Age 18 years or older.

Exclusion Criteria:

- Revision arthroplasty.

- Prior open shoulder surgery.

- Concomitant tendon transfer (Latissimus Dorsi, Pectoralis Tendon, Lower Trapezius) - Diagnosis of rheumatoid arthritis, infection, acute trauma or instability.

- Patients not willing to undergo a standardized physical therapy protocol or home therapy program after surgical intervention.

- Patient anatomy does not accommodate the study implants per surgeon discretion.

- Pregnant, patient-reported.

- Minors (under 18 years of age) - Cognitively impaired based on a diagnosis of dementia, psychiatric disorder, or any cognitive deficit that will not allow for proper informed consent or answering of study questionnaires

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05297305
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	William Beaumont Hospitals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alex Martusiewicz, MD
Principal Investigator Affiliation	Beaumont Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthritis Shoulder, Rotator Cuff Injuries

Additional Details

This study aims to determine if active external rotation two years postoperatively varies based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty (RTSA). The study also aims to determine whether active forward elevation, abduction, scapular notching, and functional outcomes two years postoperatively vary based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty. Patients undergoing primary RTSA by Dr. J. Michael Wiater, Dr. Brett Wiater, or Dr. Alexander Martusiewicz at Beaumont Health will be screened for eligibility. Following informed consent, participants will be randomised (1:1) to one of the following groups: 1) RTSA with inlay humeral component (Tornier Perform Stem Reverse+) or 2) RTSA with onlay humeral component (Tornier Ascend Flex stem). At baseline, participants will complete study questionnaires, receive a range-of-motion (ROM) exam, and standard of care x-rays and computed tomography (CT) scans. These evaluations will be repeated at 3 months, 12 months and 24 months.

Arms & Interventions

Arms

Active Comparator: Onlay Component-Tornier Ascend Flex stem

Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)

Active Comparator: Inlay Component-Tornier Perform Stem Reverse+

Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)

Interventions

Device: - Tornier Ascend Flex stem

Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)

Device: - Tornier Perform Stem Reverse+

Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

William Beaumont Hospital, Royal Oak, Michigan

Status

Recruiting

Address

William Beaumont Hospital

Royal Oak, Michigan, 48073

Site Contact

Grace SanAgustin, BSN

[email protected]

248-551-6679

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