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Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

NCT04821180 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 63

Last updated 2021-03-29

No results posted yet for this study

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

Interventions

PROCEDURE

Three and four-part proximal humeral fractures' treatment

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

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    lead OTHER

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-01-31
Completion
2021-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821180 on ClinicalTrials.gov