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Completed

NCT Number: NCT04821180

Psychological Health Influences the Choice of Device in Proximal Humeral Fractures

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.

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Key information

Conditions

Humeral Fracture, Proximal Fractures, Bone Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Three and four-part proximal humeral fractures' treatment

Procedure

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

Primary outcomes

  1. Change in Constant's score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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