Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

NCT ID: NCT04520087

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-13
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to evaluate the clinical and radiographic results after surgical treatment with implant-free allograft in the treatment of Anterior Shoulder Dislocation and to assess the safety of the surgery.

Detailed Description

Patients will be informed about the study and potential risks. All patients giving written informed consent will undergo a screening visit to assess the eligibility criteria.

Patients who meet the eligibility requirements will perform a pre-treatment visit in order to assess their healthy state. Also, patients will undergo to the radiographic visit (RX and TX) as request by clinical practice.

All the patients will be treated with arthrotomy mini-open technique with bone allograft at the site of the shoulder lesion.

After surgery all the patients will be followed up to 24 months through clinical and radiographic visits.

Conditions

Anterior Shoulder Dislocation; Bone Defects; Shoulder Instability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

allograft fixation

Patients with anteroinferior shoulder instability will be clinically treated with a mini-open arthrotomic technique involving the fixation of the corticospongeous bone graft on the glena.

Group Type: EXPERIMENTAL

allograft fixation

Intervention Type: PROCEDURE

Patients with anteroinferior shoulder instability will be clinically treated with a mini-open arthrotomic technique involving the fixation of the corticospongeous bone graft on the glena.

Interventions

allograft fixation

Patients with anteroinferior shoulder instability will be clinically treated with a mini-open arthrotomic technique involving the fixation of the corticospongeous bone graft on the glena.

Intervention Type: PROCEDURE

Other Intervention Names

bone grafting for shoulder instability

Eligibility Criteria

Inclusion Criteria

• antero.inferior shoulder instability with bone loss

Exclusion Criteria

• Patients incapable of understanding or wanting;
• Patients suffering from: rheumatic diseases, diabetes, infectious processes, congenital ligament laxity, epilepsy, severe osteoporosis.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrico Guerra, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Daniele Andreani

Role: CONTACT

daniele.andreani@ior.it

0516366072

Facility Contacts

Daniele Andreani, M.Sc.

Role: primary

Other Identifiers

J-Plasty

Identifier Type: -

Identifier Source: org_study_id