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

Recruiting

• Conditions: Proximal Humeral Fractures
• Interventions: Device: Proximal humeral fracture fixation

• Registration Number: NCT06354894
• Lead Sponsor: University of Turin, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2024-03-18
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• dementia
• psychiatric disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients affected by proximal humeral fracture	Proximal humeral fracture fixation	-

Primary Outcome Measures

Name	Time	Method
Quick Disabilities of the arm, shoulder and hand (DASH) score	1 year	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)
Radiographic outcomes	1 year	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
Oxford Shoulder Score (OSS)	1 year	Patient reported outcome. Score from 0 to 48 points (with the higher score being the better)
Subjective Shoulder Value (SSV)	1 year	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)

Trial Locations

Locations (1)

San Luigi Gonzaga Hospital; 🇮🇹 Orbassano, Turin, Italy