Clinical Trials Directory

Trials / Completed

CompletedNCT04821180

Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

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

Status
Completed
Phase
Study type
Observational
Enrollment
63 (actual)
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREThree and four-part proximal humeral fractures' treatmentOpen Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty

Timeline

Start date
2016-01-01
Primary completion
2019-01-01
Completion
2021-03-01
First posted
2021-03-29
Last updated
2021-03-29

Source: ClinicalTrials.gov record NCT04821180. Inclusion in this directory is not an endorsement.