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:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT04701268
Eligibility Criteria:
Inclusion Criteria:
* Patients aged ≥40 years
* Cuff failure with associated shoulder destruction which would be suited for hemiarthoplasty
* Shoulder joint destruction in which known alternatives would constitute either a high patient risk or a high functional failure risk.
* Shoulder destruction for which reverse total shoulder replacement would be a high risk for medical reasons (longer operation, more blood loss) or for advanced glenoid bone destruction
* Written informed consent
Exclusion Criteria:
* Systemic contraindication according to internal medical and anesthesiological standards (e.g. Renal disease, Cardiopulmonary Disease, Heart Disease, Medication including Anticoagulation, Poorly controlled diabetes mellitus, Immunosuppressive drugs etc)
* Neuroarthropathy
* Moderate to severe motor axillary nerve dysfunction
* Moderate to severe destruction of deltoid muscle
* Fracture of the scapular spine or displaced fracture of the basis of the acromion
* Fracture of the base of the coracoid
* Destruction of more than superior one third of the humeral shaft
* Chronic inflammatory diseases,which the PI estimates contribute to a higher risk of surgery complications
* Inability to cooperate with postoperative regimen or to understand the trial information
* Impaired judgement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04701268
Study Brief:
Protocol Section:
NCT04701268