Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

Angle Stable Plate Versus Reverse Shoulder Treatment for Proximal Humeral Fractures: Should the Psychological Health Influence the Choice of Device

It was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (Open Reduction and Internal Fixation) (group A) and with RSA (Reverse Shoulder Arthroplasty) (group B) for three and four-part proximal humeral fractures according to Neer classification system. One independent observer performed clinical and a psychological evaluation at one(T0), six(T1) and twelve months(T2) postoperatively.

The Constant's score and The Disabilities of the Arm, Shoulder and Hand (DASH score) were used for clinical evaluation, while General Anxiety Disorder-7 (GAD-7) and Caregiver Strain Scale (CSS) were used for psychological evaluation.

Study Overview

• Status: Completed
• Conditions: Humeral Fracture, Proximal
• Intervention / Treatment: Procedure: Three and four-part proximal humeral fractures' treatment

• Study Type: Observational
• Enrollment (Actual): 63

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects affected by proximal humeral fractures

Description

Inclusion Criteria:

• Three and four-part proximal humeral fractures according to Neer classification system;
• Patients seventy years or older;
• Shoulder surgery within one week after trauma

Exclusion Criteria:

• Exposed fractures;
• Pathological fractures;
• Proximal humerus fractures with metaphyseal or diaphyseal extension;
• Contraindications to surgery associated with organ dysfunctions or with coagulopathy;
• Allergy or hypersensitivity to the orthopedic implants;
• Patients who were unable to attend the different follow-ups;
• Patients with psychiatric disorders

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients treated by angle stable plate PHILOS	Procedure: Three and four-part proximal humeral fractures' treatment; Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty
patients treated by reverse total shoulder arthroplasty SMR	Procedure: Three and four-part proximal humeral fractures' treatment; Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Constant's score	The shoulder functionality was quantified using the Constant's score ranging between 0 (most disability) and 100 points (least disability).	T0 (one-month), T1 (six months), T2 (one year) post operatively

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Reverse shoulder arthroplasty; Open reduction and fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: HUMERUS-PSY

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No