A Study of the Comprehensive Shoulder System With Nano Humeral Component in Total Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 24
- 主要终点
- American Shoulder and Elbow Surgeon's Score (ASES)
研究概览
简要总结
The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).
详细描述
The purpose of this clinical investigation is to establish the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty. Safety and efficacy of the device will be measured by collection and analysis of the following data at the two-year or greater time point (22 months post-operative or longer):
- American Shoulder and Elbow Surgeons (ASES) Score
- Single Assessment Numeric Evaluation (SANE)
- Constant Score
- Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence
- Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for whom the surgeon has confirmed intraoperatively, has no cyst > 1cm and not more than one cyst at the implantation site
- •Patients with non-inflammatory degenerative joint disease including osteoarthritis.
- •Patients where the device will be used in the correction of a functional deformity (deformities preventing congruent articulation of the glenohumeral joint)
- •Patients with pain and/or loss of function in the shoulder for whom other treatment modalities have been unsuccessful.
- •Patients requiring unilateral or staged bilateral shoulder arthroplasty
- •Patient must be anatomically and structurally suited to receive the implants (humeral neck must be of sufficient diameter to implant at least the smallest nano humeral component and the humeral neck is intact).
- •Patients who are 21-90 years of age at the time of surgery and have reached skeletal maturity.
- •Patients with an ASES score ≤ 40.
排除标准
- •Patients diagnosed with avascular necrosis or post-traumatic arthritis of the humeral head
- •Patients found at the time of intraoperative examination to have a single cyst >1 cm in size or multiple cysts at the implantation site
- •Patient presents with shoulder joint infection, sepsis, osteomyelitis or distant foci of infections which may spread to the implant site.
- •Patients with cuff tear arthropathy.
- •Patients who have undergone a Hemi-, Total, or Reverse Total Shoulder arthroplasty in the affected shoulder.
- •Patient presents with a malunion or non-union of the tuberosities of the proximal humerus.
- •Patients with osteoporosis, osteomalacia, rheumatoid arthritis, metabolic disorders of bone, muscle or connective tissue, gross deformity or any other condition of the proximal humerus (defined as severe destruction or deformity of the proximal humerus that precludes placement of the device) that in the Investigator's medical judgment could compromise implant fixation or bone healing.
- •Rapid bone destruction, marked bone loss or bone resorption apparent on roentgenogram.
- •Patients with neurologic or other disorders that would either affect the stability of the shoulder prosthesis, i.e., Charcot's joint, uncontrolled seizures, etc., or would affect their capability or willingness to return to the clinic for assessments and/or follow directions.
- •Bone cancer, either primary or secondary, that affects the shoulder.
- •Patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery)
- •Patients with a life expectancy of less than three years.
- •Patients diagnosed with severe shoulder instability
- •Patients diagnosed with subscapularis incompetence
- •Patients diagnosed with any condition that may limit their ability to complete the consent form or would affect their capability or willingness to return to the clinic for assessments and/or follow directions (i.e. mental illness)
- •Patients with known metal allergy
- •Patients who refuse to sign the Institutional Review Board (IRB) approved consent form
- •Patients who are found intraoperatively to require a specific treatment and are unable to be randomized.
结局指标
主要结局
American Shoulder and Elbow Surgeon's Score (ASES)
时间窗: 22+ Months
The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.
Number of Shoulders With Radiographic Success
时间窗: 2 years
This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "Subsidence of the humeral component \<5 mm, and migration of the humeral component \<5 mm, and no progressive lucency around the humeral component \>2 mm in two or more contiguous zones, and migration of the glenoid component \<5 mm, and no progressive lucency \>2 mm around the entire glenoid component." All subject records were evaluated by an Independent Radiographic Reviewer (IRR) at each time point for radiographic success based on these criteria.
Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation
时间窗: 2 years
This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as "No unanticipated device-related adverse event, and no fracture, perforation of the bone or joint dislocation, and no fracture, perforation or dissociation of the device, and no revision or removal of any component." All subject records were evaluated for each of the disqualifying factors, and all subjects that failed at least one of the endpoint measures were identified. The success rate is defined as the number of subjects at two years not meeting any of the disqualifying factors compared to the total number of cases present at two years plus all subjects considered failures without two year data.
次要结局
- Constant Score Adjusted for Age and Gender(Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years)
- Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence(2+ years)
- American Shoulder and Elbow Surgeon's Score (ASES)(Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years)
- Single Assessment Numeric Evaluation (SANE) Score(6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years)