NCT04520087

Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2020-10-13
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2020-08-20
• Last updated: 2025-06-26

Locations

1 site across 1 country: Italy