Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

Humeral Fracture, Proximal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821180
• Other study ID #: HUMERUS-PSY
• Status: Completed
• Start date: January 2016
• Est. completion date: March 2021

Study information

• Verified date: March 2021
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2021
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fracture, Proximal
• Humeral Fractures
• Shoulder Fractures

Intervention

Procedure:
• Three and four-part proximal humeral fractures' treatment
Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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