Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT05297305
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05297305
Study Brief:
Protocol Section:
NCT05297305