Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Anterior Shoulder Dislocation
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change from Baseline in DASH score at 24th months
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Change from Baseline in DASH score at 24th months
Time Frame: 24 months
The Disabilities of the Arm, Shoulder and Hand (DASH) Score is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Secondary Outcomes
- Change from baseline in DASH score(Baseline, 1, 3, 6, and 12 months)
- Change from Baseline in Constant score(Baseline, 1, 3, 6, 12 and 24 months)
- Change from Baseline in Rowe score(Baseline, 1, 3, 6, 12 and 24 months)
- Evaluation of the Allograft integration(6 and 12 months)
- Change from Baseline in EQ-5D-3L (EuroQoL) CurrentHealthAssessment:(Baseline, 1, 3, 6, 12 and 24 months)
- Evaluation of the grade of the Shoulder Osteoarthritis through Kellgren-Lawrence scoring(24 months)