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

Signe Rosner Rasmussen42 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Shoulder Fractures

Interventions

Reverse Total Shoulder ArthroplastyDEVICE

The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.

HemiarthroplastyDEVICE

The shoulder hemiarthroplasty

Eligibility

Sex: ALLMin age: 65 YearsMax age: 120 Years

Medical Language ↔ Plain English

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)

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.

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

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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).

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

Central Contacts

Signe R Rasmussen, MD

CONTACT

+4526623427 signe.nanna.rosner.rasmussen.01@regionh.dk

Data from ClinicalTrials.gov

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