Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Anterior Shoulder Dislocation; Shoulder Instability; Bone Defects

Treatments: Procedure: allograft fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT04520087

J-Plasty

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

allograft fixation

Experimental group

Description:

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.

Treatment:

Procedure: allograft fixation