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Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

A

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status

Completed

Conditions

Humeral Fracture, Proximal

Treatments

Procedure: Three and four-part proximal humeral fractures' treatment

Study type

Observational

Funder types

Other

Identifiers

NCT04821180
HUMERUS-PSY

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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

Trial design

63 participants in 2 patient groups

patients treated by angle stable plate PHILOS
Treatment:
Procedure: Three and four-part proximal humeral fractures' treatment
patients treated by reverse total shoulder arthroplasty SMR
Treatment:
Procedure: Three and four-part proximal humeral fractures' treatment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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