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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Fractures
• Intervention / Treatment: Device: Reverse Total Shoulder Arthroplasty; Device: Hemiarthroplasty

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Signe R Rasmussen, MD; Phone Number: +4526623427; Email: signe.nanna.rosner.rasmussen.01@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 120 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RTSA group; Participants with a complex proximal humerus fracture given a RTSA	Device: Reverse Total Shoulder Arthroplasty; The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
ACTIVE_COMPARATOR: Hemiarthroplasty group; Historical cohort of participants, operated with a hemiarthroplasty of the shoulder	Device: Hemiarthroplasty; The shoulder hemiarthroplasty

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Signe Rosner Rasmussen
• Collaborators: Herlev and Gentofte Hospital
• Investigators: Study Chair: Bo S Olsen, Professor, Herlev and Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2024
• Study Completion (ANTICIPATED): August 1, 2024

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 8, 2020
• First Posted (ACTUAL): August 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Humeral Fractures, Proximal
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: 71005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes