A 2-Year Prospective Follow-up Study of the Global Unite Reverse Fracture Shoulder System for Proximal Humerus Fractures

Signe Rosner Rasmussen

Status: Not yet enrolling

Conditions: Shoulder Fractures

Treatments: Device: Reverse Total Shoulder Arthroplasty; Device: Hemiarthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04507880

71005

Details and patient eligibility

About

The objective of this study is to evaluated the efficacy and safety of the reverse total shoulder prosthesis (RTSA) for complex proximal humerus fractures. The clinical results of RTSA will be compared to clinical results from a historical cohort, that received a hemiarthroplasty of the shoulder.

Enrollment: 42 estimated patients

Sex: All

Ages: 65 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fracture or fracture dislocation not suitable for non-operative treatment or for osteosynthesis due to displacement and comminution
• Patients older than 65-years of age, or younger than 65-year of age if the surgeon assesses the physiological age as older.
• All patients, regardless of age, with an insufficient or irreparable rotator cuff

Exclusion criteria

• Brachial plexus palsy
• Previous ipsilateral fracture of clavicula, scapula, or proximal humerus
• Cognitive disabilities or substance abuse enabling rehabilitation and follow-up
• Patients without a Danish civil registration number

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

RTSA group

Experimental group

Description:

Participants with a complex proximal humerus fracture given a RTSA

Treatment:

Device: Reverse Total Shoulder Arthroplasty

Hemiarthroplasty group

Active Comparator group

Description:

Historical cohort of participants, operated with a hemiarthroplasty of the shoulder

Treatment:

Device: Hemiarthroplasty