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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04821180

Enrollment

Registered

2021-03-29

Start date

2016-01-31

Completion date

2021-03-31

Last updated

2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Humeral Fracture, Proximal

Keywords

Open reduction and fixation, Reverse shoulder arthroplasty

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.

Interventions

PROCEDUREThree and four-part proximal humeral fractures' treatment

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

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026