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

Study Overview
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Brief Summary
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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.

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

Conditions
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Shoulder Fractures

Intervention / Treatment
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* Device: Reverse Total Shoulder Arthroplasty
* Device: Hemiarthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RTSA group<br>Participants with a complex proximal humerus fracture given a RTSA | Device: Reverse Total Shoulder Arthroplasty<br>* The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.<br>|
| Active Comparator: Hemiarthroplasty group<br>Historical cohort of participants, operated with a hemiarthroplasty of the shoulder | Device: Hemiarthroplasty<br>* The shoulder hemiarthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Constant score (CS) | 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. | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oxford Shoulder Score (OSS) | The OSS is a patient related outcome-measure (PROM) validated for evaluating self-assessed functionality after shoulder surgery. The 12 questions, with five response options, gives a total score ranging from 12 points (no pain or functional impairment) to 60 points (worst). | 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 WOOS is a patient-related outcome measurement, initially validated for patients with osteoarthritis of the shoulder. On four domains (physical symptoms, recreation/work, lifestyle, emotions) the visual analog scale measures shoulder-related quality-of-life with a maximum of 1900 points, which signifies highest quality of function. | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | 
| Change in EQ5D questionnaire | The EQ-5D (EuroQuol 5 Dimension scale) questionnaire is a widely used patient-related outcome measurement for quality of life assessment in general, consisting of 25 dichotomous questions from five parameters and a visual analog scale to plot perceived health. A persons selfperceived health status is then evaluated as a 5-digit number, ranging from 11111 (having no problems) to 33333 (having problems in all 5 aspects), and as a number from 0 (worst imaginable health) to 100 (best imaginable health). | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | 
| Change in Numeric Ranking Scale | Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain. | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | 
| Complications | Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant. | The outcome is registered 2 years after surgery | 
| Change in humeral tuberosities | Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays. | The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humeral Fractures, Proximal