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Clinical Trials/NCT06354894
NCT06354894
Recruiting
Not Applicable

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

University of Turin, Italy1 site in 1 country120 target enrollmentStarted: November 1, 2020Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
University of Turin, Italy
Enrollment
120
Locations
1
Primary Endpoint
Quick Disabilities of the arm, shoulder and hand (DASH) score

Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • psychiatric disease

Outcomes

Primary Outcomes

Quick Disabilities of the arm, shoulder and hand (DASH) score

Time Frame: 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

Time Frame: 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)

Time Frame: 1 year

Patient reported outcome. Score from 0 to 48 points (with the higher score being the better)

Subjective Shoulder Value (SSV)

Time Frame: 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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Turin, Italy
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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