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

Signe Rosner Rasmussen0 sites42 target enrollmentAugust 1, 2020

ConditionsShoulder Fractures

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Shoulder Fractures
Sponsor: Signe Rosner Rasmussen
Enrollment: 42
Primary Endpoint: Change in Constant score (CS)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2020

End Date

August 1, 2024

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Signe Rosner Rasmussen

Responsible Party

Sponsor Investigator

Principal Investigator

Signe Rosner Rasmussen

MD, orthopedic resident, principal investigator

Herlev and Gentofte Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Constant score (CS)

Time Frame: The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery

The CS consists of four parameters (pain, mobility, ADL, strength) assessing shoulder function after the treatment of shoulder injury, both subjectively and objectively. The scale rates from worst (0) to best (100) quality of shoulder function.

Secondary Outcomes

Change in Oxford Shoulder Score (OSS)(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
Change in EQ5D questionnaire(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
Change in Numeric Ranking Scale(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
Change in humeral tuberosities(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
Change in Western Ontario Osteoarthritis of the Shoulder Index (WOOS)(The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery)
Complications(The outcome is registered 2 years after surgery)