Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

Completed

• Conditions: Humeral Fracture, Proximal
• Interventions: Procedure: Three and four-part proximal humeral fractures' treatment

• Registration Number: NCT04821180
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2019-01
• Status Verified: 2021-03
• Study Completion: 2021-03
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-26
• Last Update Submitted: 2021-03-26
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients treated by reverse total shoulder arthroplasty SMR	Three and four-part proximal humeral fractures' treatment	-
patients treated by angle stable plate PHILOS	Three and four-part proximal humeral fractures' treatment	-

Primary Outcome Measures

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