Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID04520087

Evaluation of Clinical and Radiographic Results After Surgical Treatment Using Implant-Free Bone Allograft for Anterior Shoulder Dislocation Pilot Study

Led by Istituto Ortopedico Rizzoli · Updated on 2025-06-26

20

Participants Needed

1

Research Sites

272 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the clinical and X-ray results after surgical treatment using an implant-free bone graft for patients with anterior shoulder dislocation and related bone defects. The study also assesses the safety of this surgical method in treating shoulder instability. All patients will undergo a mini-open arthrotomy surgery where a bone allograft is fixed to the shoulder lesion site to address anteroinferior shoulder instability. Before treatment, patients will have a screening visit to confirm eligibility, followed by a pre-treatment visit to evaluate their health and necessary X-rays. After surgery, patients will be followed with clinical and radiographic visits for up to 24 months. Participants will be monitored through regular clinical assessments and imaging to track changes and recovery. The main outcome measured is the change in the DASH score, a tool that evaluates arm, shoulder, and hand function, at 24 months after treatment. Safety and overall healing will be closely observed during the follow-up period.

CONDITIONS

Official Title

Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Anteroinferior shoulder instability with bone loss
Not Eligible

You will not qualify if you...

  • Unable to understand or unwilling to participate
  • Rheumatic diseases
  • Diabetes
  • Infectious processes
  • Congenital ligament laxity
  • Epilepsy
  • Severe osteoporosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

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Research Team

D

Daniele Andreani

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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