Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

NCT ID: NCT04821180

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-03-31

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.

Conditions

Humeral Fracture, Proximal

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

patients treated by angle stable plate PHILOS

Three and four-part proximal humeral fractures' treatment

Intervention Type: PROCEDURE

Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty

patients treated by reverse total shoulder arthroplasty SMR

Three and four-part proximal humeral fractures' treatment

Intervention Type: PROCEDURE

Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty

Interventions

Three and four-part proximal humeral fractures' treatment

Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HUMERUS-PSY

Identifier Type: -

Identifier Source: org_study_id