Percutaneous Pinning Versus Plate and Screws for Surgical Fixation of Proximal Humeral Fractures

Riduzione e Sintesi Delle Fratture Del Terzo Prossimale d'Omero: Confronto Prospettico Tra Placca e Viti e Pinning Percutaneo

The aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws.

Study Overview

• Status: Recruiting
• Conditions: Proximal Humeral Fractures
• Intervention / Treatment: Device: Proximal humeral fracture fixation

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Enrico Bellato, MD; Phone Number: +393406429207; Email: enrico.bellato@unito.it

Study Locations

• Italy
  • Turin
    • Orbassano, Turin, Italy, 10043
      • Recruiting
      • San Luigi Gonzaga Hospital
      • Contact: Enrico Bellato, MD; Phone Number: +393406429207; Email: enrico.bellato@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by proximal humeral fractures who consent to participate the study and whose fracture was considered to be treated with surgical fixation either with percutaneous pinning or with plate and screws

Description

Inclusion Criteria:

• > 18 year old
• proximal humeral fracture
• both X-rays and CT scan available

Exclusion Criteria:

• dementia
• psychiatric disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients affected by proximal humeral fracture	Device: Proximal humeral fracture fixation; percutaneous pinning VS plate and screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Shoulder Score (OSS)	Patient reported outcome. Score from 0 to 48 points (with the higher score being the better)	1 year
Quick Disabilities of the arm, shoulder and hand (DASH) score	The questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms ranging from 0 (no disability) to 100 (most severe disability)	1 year
Subjective Shoulder Value (SSV)	The subjective shoulder value is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder during ADLs (from 0% to 100%, with the higher score being the better)	1 year
Radiographic outcomes	Shoulder x-rays will be reviewed by a panel of experts in shoulder traumatology who will be asked to define the result as: normal; nonunion; malunion; avascular necrosis; infection	1 year

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Arm Injuries; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: MACOXS; 133/2020/U (Registry Identifier: MACOXS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No