Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Baseline in DASH score at 24th months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •antero.inferior shoulder instability with bone loss
排除标准
- •Patients incapable of understanding or wanting;
- •Patients suffering from: rheumatic diseases, diabetes, infectious processes, congenital ligament laxity, epilepsy, severe osteoporosis.
研究组 & 干预措施
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.
干预措施: allograft fixation (Procedure)
结局指标
主要结局
Change from Baseline in DASH score at 24th months
时间窗: 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.
次要结局
- 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)