A Prospective, Randomized, Multicenter Study Comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder Prothesis to the Univers™ II Shoulder Prosthesis in Patients With a Degenerative Joint Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 303
- 试验地点
- 32
- 主要终点
- Composite Clinical Success
研究概览
简要总结
A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a degenerative joint disease.
详细描述
The purpose of this study is to demonstrate non-inferiority of the Arthrex Eclipse™ Shoulder Prosthesis to the Arthrex Univers™ II Shoulder Prosthesis for the treatment of degenerative joint disease in subjects who are candidates for total shoulder replacement. Non-inferiority in terms of safety and effectiveness will be measured by a 2 year composite clinical success (CCS) that requires functional improvement, radiographic success, absence of reoperations and revision, and lack of serious device-related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is > 21 years of age
- •The subject has continued symptoms in target shoulder despite at least 3 months of other treatment modalities(e.g.: anti-inflammatory, physical therapy and steroid injections)
- •The subject has a diagnosis in the target shoulder of one or more of the following:
- •osteoarthritis, avascular necrosis, post-traumatic arthritis, or rheumatoid arthritis.
- •The subject presents with pain and functional impairment in the index shoulder, measured by an Adjusted Constant Score of ≤
- •Note: The Adjusted Constant Score will be calculated from the raw Constant Score to establish patient eligibility.
- •The subject is willing to receive implantation of the Arthrex™ Shoulder Prosthesis or Univers™ II Shoulder Prosthesis.
- •The subject must be physically and mentally willing and able to comply with all study procedures (including follow-up visits and radiographic assessments) until the conclusion of the study.
- •The subject has been informed of the nature of the study and provided written consent as approved by the sites local Institutional Review Board or Ethic Review Board.
排除标准
- •The subject is likely a candidate for hemi-humeral arthroplasty (i.e.: Avascular Necrosis of the humeral head without glenoid involvement (Stages 0-3): Rotator Cuff Deficient Shoulder: Glenoid Bone deficiency/deformity that precludes glenoid replacement (Walch Type B2 or C) or Fractures of the Proximal Humerus, without Glenoid involvement.
- •The subject has immature bone as defined by the absence of cancellous bone patterning, a mature, thick cortex, and stress lines within the cancellous bone.
- •The subject has obvious defects in bone quality, such as cysts or lesions, in the humeral head of the target shoulder, as demonstrated by radiographic evaluation.
- •The subject has a target shoulder a rotator cuff that is not intact and not reconstructible.
- •The subject has Irreducible 3- and 4- part proximal humeral fractures of the target shoulder.
- •The subject has documented history of foreign-body sensitivity.
- •Subject with positive pregnancy test, or lactating, or intends to become pregnant during treatment period
- •The subject has history of Schizophrenia, Bipolar Disorder and/or Major Depressive Disorder as defined by DSM IV.
- •The subject is skeletally immature demonstrated radiographically by incomplete closure of proximal humeral epiphyses.
- •The subject is at high risk for poor healing or confounding outcomes [(i.e.: clinically significant renal, hepatic, cardiac hematologic disease or endocrine disease)]
- •The subject is on immune-stimulating or immunosuppressive agents
- •The subject has co-morbidity that reduces life expectancy < 36 month.
- •The subject seeking or receiving workman's compensation for shoulder injury,
- •The subject is > 350 lbs.
- •The subject engaged in heavy labor (e.g. repetitive lifting in the excess of more than 50 lbs.)
- •The subject has had surgery in the affected shoulder in the last 12 months (with the exception of diagnostic arthroscopy without reconstruction or repair procedures)
- •The subject is engaged in active sports participation. (e.g. weight lifting involving upper extremities or involved in contact sports)
- •The subject is taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids with the exception of topical and/or inhalers)
- •The subject is a prisoners or wards of the state
- •The subject has a history of alcohol and/or substance abuse as defined by DSM IV (Diagnostic and Statistical Manual Diploma in Social Medicine)
- •The subject has an active or chronic infection, either systemic or local.
- •The subject has pathologic fractures of the affected shoulder
- •The subject has acute trauma of the affected shoulder
- •The subject has osteoporosis defined as a bone density T score of < or = -2.
- •(A screening Questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation) and MORES (Male Osteoporosis Risk Estimation Score), will be used to screen patients who require a DEXA (dual energy x-ray absorptiometry) bone mineral density measurement.
结局指标
主要结局
Composite Clinical Success
时间窗: 2 year
To be considered a success, the eclipse subject must meet the following composite clinical success criteria: 1. An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is \> or = to 10 and a final Adjusted Constant Score \> or + to 54. 2. Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol. 3. No reoperation, removal or modification of any study component up to the subject's completion of the study. 4. No serious device-related complications up to the subject's completion of the study.
次要结局
未报告次要终点