Evaluating surgical treatment outcomes for anterior shoulder dislocation
Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study
This study is testing a new surgery technique for people with shoulder dislocations and bone loss to see how well it helps them recover and feel stable again.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT04520087 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the clinical and radiographic outcomes following surgical treatment of anterior shoulder dislocation using an implant-free allograft technique. Eligible patients will undergo a screening process and pre-treatment evaluations before receiving surgery through a mini-open arthrotomy approach. Post-surgery, participants will be monitored for up to 24 months to evaluate the effectiveness and safety of the procedure. The study focuses on patients with bone loss associated with shoulder instability.
Who should consider this trial
Good fit: Ideal candidates are individuals with antero-inferior shoulder instability accompanied by bone loss.
Not a fit: Patients with conditions such as rheumatic diseases, diabetes, or severe osteoporosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve recovery and stability for patients suffering from anterior shoulder dislocation without the need for implants.
How similar studies have performed: While similar approaches have been explored, this specific method using implant-free allograft is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Enrico Guerra, MD — Istituto Ortopedico Rizzoli
- Study coordinator: Daniele Andreani
- Email: daniele.andreani@ior.it
- Phone: 0516366072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.