Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 22
- 主要终点
- The Number of Device Related Serious Adverse Events.
研究概览
简要总结
The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.
详细描述
The primary objectives of this study are to evaluate the safety and efficacy (defined as follows) of the Sidus Stem-Free Shoulder System in unilateral primary total shoulder arthroplasty.
Safety: Will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects (UADEs) in investigational subjects as well as analyzing survivorship using revision or intended revision as an endpoint.
Efficacy: Will be determined by comparing the overall pain and functional performance, survivorship and radiographic success of investigational subjects with those subjects who received the control devices.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 22 years of age or older.
- •Patient is skeletally mature.
- •Patient must have signed the IRB/EC approved informed consent.
- •Patient is a candidate for a total shoulder arthroplasty (replacement of humeral head and glenoid).
- •Patient has a diagnosis of primary osteoarthritis of the shoulder of grade III or higher.
- •Patient has experienced symptoms of shoulder pain and/or loss of function for at least 6 months and has a maximum ASES score of
- •Patient has no findings to indicate an etiology of acute trauma, infection, avascular necrosis or inflammatory arthropathy of the operative shoulder.
- •Patient has undergone no previous reconstructive shoulder surgery. Acceptable previous shoulder surgeries include arthroscopy, soft tissue repair, or pinning/screw fixation due to a historic fracture.
- •Patient is willing and able to comply with the required post-operative therapy as defined in the protocol.
- •Patient is willing and able to comply with the required follow-up schedule as defined in the protocol.
排除标准
- •Patient is a prisoner.
- •Patient is a known current alcohol or drug abuser.
- •Patient has a psychiatric illness or cognitive deficit that precluded informed consent.
- •Patient has a chronic renal impairment or failure.
- •Patient sensitivity to implant materials.
- •Patient has a vascular insufficiency due to large or small vessel disease which could inhibit postoperative healing.
- •Patient is currently receiving or has received within the last 3 months chronic systemic or inhaled steroids. This exclusion does not apply to those patients with occasional inhaler use due to seasonal allergies.
- •Local rash or skin infection around the intended operative site.
- •Patients with ongoing Worker's Compensation or third party liability claims related to the operative shoulder.
- •Pre-existing contra-lateral shoulder replacement less than 6 months ago.
- •Patient who will require a contra-lateral shoulder replacement less than 6 months from the current planned shoulder replacement.
- •Patient has evidence of major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, or previous shoulder surgery (other than arthroscopy, soft tissue repair, or pinning/screw fixation due to historic fracture).
- •Patient has significant muscle paralysis.
- •Patient has Charcot arthropathy.
- •Patient has metaphyseal bony defects at the bone/implant interface which could inhibit prosthesis fixation.
- •Patient has a preoperative computed tomography scans or other radiographic images of the shoulder that showed insufficient glenoid or humeral bone stock to allow for implantation of the prosthesis.
- •Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis or severe osteopenia), cancer and radiation.
- •Patient with severe glenoid deficiency.
- •Prior fracture of the operative shoulder with the presence of malunion or non-union.
- •Prior tuberosity fracture with the presence of malunion or non-union.
- •Patient has an active joint or systemic infection.
- •Patient has a life expectancy of less than two years.
- •Patient with unacceptably high operative risk.
- •Patient unwilling to sign protocol required informed consent.
- •Patient is unwilling to complete the protocol required radiographic imaging.
- •Patient is unwilling to complete the protocol required follow-up of two years.
- •Patient is known to be pregnant.
- •Intraoperative findings which indicate insufficient bone stock or local deformities which could inhibit prosthesis fixation. Final assessment of bone quality will be completed intraoperatively upon resection of the humeral head and prior to insertion of the anchor as described in the surgical technique. If there is any doubt regarding bone quality affecting the stable fixation of the anchor, the surgeon must use a stemmed prosthesis.
研究组 & 干预措施
Investigational
This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.
干预措施: Sidus Stem-Free Total Shoulder Arthroplasty System (Device)
结局指标
主要结局
The Number of Device Related Serious Adverse Events.
时间窗: Two years
This outcome will measure the frequency of device related serious adverse events.
Survivorship
时间窗: Up to Two years
The Kaplan-Meier method was used for this study. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 2 years post-operative (whichever came first).
Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment
时间窗: Two years
absence of radiographic evidence of pending failure of the humeral components, assessed at 2 years which may include the following: * implant fracture * progressive implant migration or subsidence ≥ 5 mm
Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
时间窗: Two years
Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
次要结局
- ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire(6 weeks, 6 months, and 1 year)
- SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire.(Pre-Op, 6 weeks, 6 months, 1 year and 2 years)