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

NCT06354894 | Recruiting FDA Device

• 2 other identifiers: MACOXS133/2020/U
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Humeral Fractures

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Patients affected by proximal humeral fracture

Device: Proximal humeral fracture fixation

Interventions

Proximal humeral fracture fixation DEVICE

percutaneous pinning VS plate and screws

Patients affected by proximal humeral fracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• dementia
• psychiatric disease

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

San Luigi Gonzaga Hospital

Orbassano, Turin, 10043, Italy

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Central Study Contacts

Enrico Bellato, MD

CONTACT

+393406429207; enrico.bellato@unito.it

Study Design

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

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 9, 2024
• Study Start: November 1, 2020
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

IT (1)