Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari (Other)

Overall Status

Completed

CT.gov ID

NCT04821180

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Humeral Fracture, Proximal	Procedure: Three and four-part proximal humeral fractures' treatment

Study Design

Study Type:

Observational

Actual Enrollment :

63 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
patients treated by angle stable plate PHILOS	Procedure: Three and four-part proximal humeral fractures' treatment Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty
patients treated by reverse total shoulder arthroplasty SMR	Procedure: Three and four-part proximal humeral fractures' treatment Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty

Arm

Intervention/Treatment

patients treated by angle stable plate PHILOS

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

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

patients treated by reverse total shoulder arthroplasty SMR

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

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

Outcome Measures

Primary Outcome Measures

Change in Constant's score [T0 (one-month), T1 (six months), T2 (one year) post operatively]
The shoulder functionality was quantified using the Constant's score ranging between 0 (most disability) and 100 points (least disability).

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

ClinicalTrials.gov Identifier:

NCT04821180

Other Study ID Numbers:

HUMERUS-PSY

First Posted:

Mar 29, 2021

Last Update Posted:

Mar 29, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Open reduction and fixation

Reverse shoulder arthroplasty

Additional relevant MeSH terms:

Fractures, Bone

Humeral Fractures

Shoulder Fractures

Study Results

No Results Posted as of Mar 29, 2021