Pivotal, Non-Randomized, Historically Controlled, Prospective, Multi-Center Clinical Study of the Easytech Reversed Shoulder System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 12
- 主要终点
- Adjusted Constant-Murley Score
研究概览
简要总结
The purpose of the study is to collect data to demonstrate the safety and effectiveness of the Easytech Reversed Shoulder System for the treatment of patients who require a reverse total shoulder arthroplasty.
详细描述
The clinical study will enroll patient who require a reverse total shoulder arthroplasty as a result of osteoarthritis, post-traumatic arthritis, avascular necrosis and have a massive and non-repairable rotator cuff tear and a functional deltoid muscle.
If patients meet the eligibility criteria, evaluations and x-rays will be completed pre-operatively and post-operatively out to 24 months.
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
盲法说明
no masking due to being a single arm study
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are 21 years or older.
- •Patients are skeletally mature as evident by scapula and proximal humerus closure.
- •Patients exhibit clinical indications for primary reverse total shoulder arthroplasty based on physical exam and medical history including the following: osteoarthritis, post-traumatic arthritis, or avascular necrosis.
- •Patients have a massive and non-repairable rotator cuff tear.
- •Patients have a functional deltoid muscle.
- •Patients are anatomically and structurally suited to receive the implants;
- •a. Subject show sufficient bone quality in the humerus bone intraoperatively via the thumb test, guide pin test, humeral punch test, and humeral anchor test as outlined in the surgical technique.
- •Patients with an adjusted Constant Score < 60 and ≥
- •Patients are willing and able to comply with the follow-up schedule and evaluation outlined in the protocol.
- •Patient are willing and able to sign the informed consent.
排除标准
- •Patients with Body Mass Index (BMI) greater than 40 kg/m
- •Patients have one of the following compromising the affected limb: a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable.
- •Patients have marked bone loss that would not allow sufficient support of the implant.
- •Patients have a known sensitivity or allergic reaction to one or more of the implanted materials.
- •Patients who are participating concurrently in another clinical study, or have participated in a clinical study within the last 90 days, or intend to during the course of the study.
- •Patients who have an active systemic infection, or an active local infection in or near the target shoulder, or have a previous history of joint infection.
- •Patients with known immunodeficiency.
- •Patients currently taking > 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
- •Patients with significant comorbidities as evident by an American Society of Anesthesiologists (ASA) score greater than
- •Patients with active neoplastic disease.
- •Patients with current drug or alcohol abuse, or a history of the same within the last 6 months.
- •Patients with local circulatory problems, (e.g. thrombophlebitis and lymphedema).
- •Patients are pregnant or expect to become pregnant during the duration of the study.
- •Patients with any mental or psychological disorder that would impair their ability to complete the study questionnaires.
- •Patients with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the patient unable to perform appropriate postoperative rehabilitation.
- •Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
- •Patients with humeral or glenoid fractures.
- •Patients unable to stand from sitting position without the use of their hands/arms.
- •Patients with a history of fragility fractures as defined as any fall from a standing height or less, that results in a fracture.
- •Patients with osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease; a. Osteoporosis is defined as Simple Calculated Osteoporosis Risk Estimation (SCORE) above 6 and DXA (Dual-energy X-ray absorptiometry) T-score < -2.5 or QCT (Quantitative computed tomography) T-score < 80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed.
结局指标
主要结局
Adjusted Constant-Murley Score
时间窗: 24 months post-operative
adjusted Constant Score of 70 or greater, no humeral radiolucency \>2mm or humeral migration/subsidence \>5mm, no revision surgery, no serious device related adverse event
no serious device related adverse event
时间窗: 24 months post-operative
there is no serious device related adverse event reported
no humeral radiolucency >2mm around the humeral component
时间窗: 24 months post-operative
on review of x-rays, there are no radiolucencies \>2mm around the humeral component
no subsidence or migration of the humeral component >5mm
时间窗: 24 months post-operative
on review of x-rays, there is no subsidence or migration of the humeral component greater than or equal to 5mm
no revision
时间窗: 24 months post-operative
there is no revision of the humeral components
次要结局
- QuickDASH(24 months post-operative)
- Visual Analog Scale for Pain (VAS)(24 months post-operative)
- American Shoulder and Elbow Surgeon (ASES)(24 months post-operative)
- Range of Motion of the shoulder joint(24 months)