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

Not Applicable

• Conditions: Shoulder Fractures
• Interventions: Device: Reverse Total Shoulder Arthroplasty; Device: Hemiarthroplasty

• Registration Number: NCT04507880
• Lead Sponsor: Signe Rosner Rasmussen

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-31
• Study Start: 2020-08-01
• Study First Submitted QC: 2020-08-08
• Last Update Submitted: 2020-08-08
• Study First Posted: 2020-08-11
• Last Update Posted: 2020-08-11
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RTSA group	Reverse Total Shoulder Arthroplasty	Participants with a complex proximal humerus fracture given a RTSA
Hemiarthroplasty group	Hemiarthroplasty	Historical cohort of participants, operated with a hemiarthroplasty of the shoulder

Primary Outcome Measures

Name	Time	Method
Change in Constant score (CS)	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 Outcome Measures

Name	Time	Method
Change in Oxford Shoulder Score (OSS)	The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery	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).
Change in EQ5D questionnaire	The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery	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).
Change in Numeric Ranking Scale	The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery	Pain measured after surgery according to the Numeric Ranking Scale (NRS), where 0 is no pain and 10 is worst imaginable pain.
Change in humeral tuberosities	The outcome is measured 3 months, 6 months, 1 year and 2 years after surgery	Migration or resorption of the humeral tuberosities accessed qualitatively from the xrays.
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	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.
Complications	The outcome is registered 2 years after surgery	Postoperative complications or reoperation due to infection, nerve damage, vascular damage, iatrogenic perioperative fracture, or loosening of the implant.