Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

NCT04821180 | Completed

• 1 other identifier: HUMERUS-PSY
• Study Type: observational
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Humeral Fracture, Proximal

Keywords

Open reduction and fixation; Reverse shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

• Change in Constant's score

  The shoulder functionality was quantified using the Constant's score ranging between 0 (most disability) and 100 points (least disability).

  T0 (one-month), T1 (six months), T2 (one year) post operatively

Study Arms (2)

patients treated by angle stable plate PHILOS

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

patients treated by reverse total shoulder arthroplasty SMR

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

Interventions

Three and four-part proximal humeral fractures' treatment PROCEDURE

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

patients treated by angle stable plate PHILOS; patients treated by reverse total shoulder arthroplasty SMR

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects affected by proximal humeral fractures

You may qualify if:

• Three and four-part proximal humeral fractures according to Neer classification system;
• Patients seventy years or older;
• Shoulder surgery within one week after trauma

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 29, 2021
• Study Start: January 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share