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

Shoulder Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04507880
• Other study ID #: 71005
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2020
• Source: Herlev and Gentofte Hospital
• Contact: Signe R Rasmussen, MD
• Phone: +4526623427
• Email: signe.nanna.rosner.rasmussen.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Shoulder Fractures

Intervention

Device:
• Reverse Total Shoulder Arthroplasty
The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
• Hemiarthroplasty
The shoulder hemiarthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Signe Rosner Rasmussen	Herlev and Gentofte Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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