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

Proximal Humeral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06354894
• Other study ID #: MACOXS
• Secondary ID: 133/2020/U
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2024
• Source: University of Turin, Italy
• Contact: Enrico Bellato, MD
• Phone: +393406429207
• Email: enrico.bellato[@]unito.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• dementia
• psychiatric disease

Related Conditions & MeSH terms

• Humeral Fractures
• Proximal Humeral Fractures
• Shoulder Fractures

Intervention

Device:
• Proximal humeral fracture fixation
percutaneous pinning VS plate and screws

Locations

Country	Name	City	State
Italy	San Luigi Gonzaga Hospital	Orbassano	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Shoulder Score (OSS)	Patient reported outcome. Score from 0 to 48 points (with the higher score being the better)	1 year
Primary	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
Primary	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
Primary	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