Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Anteroinferior shoulder instability with bone loss
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
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
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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