5- Year Follow-up in Total Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Change in Post-operative Radiographic Measurements of Prosthetic Relationships (Anteroposterior and Axillary x-rays)
研究概览
简要总结
This prospective study will evaluate the Bigliani/Flatow prosthesis. The aims of this study are to establish the safety, effectiveness, and value of the prosthetic system, and to collect information from expert shoulder surgeons as to features of the implants, instruments, and techniques which may be further improved. In this study, the investigators hypothesize that this prosthetic device will significantly improve long-term patient-based outcomes, functional status and quality of life.
详细描述
Over the last two decades, total shoulder joint replacement - or arthroplasty - has become a commonly performed procedure for the treatment of painful arthritis of the shoulder, and numerous studies have demonstrated its success. During this time, much has been learned about the efficacy, as well as the complications, of the procedure, and since its introduction in the 1950's, shoulder arthroplasty has undergone an evolution in design. The value of such innovations has not yet been determined and will depend on the results of long term follow-up studies. The purpose of this study is to provide follow-up information and design modification directives.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18 years of age or over.
- •Patient must have signed The Informed Consent and Release of Medical Information forms.
- •The patient can be a man, postmenopausal woman, or a woman who is likely to become pregnant but is using adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraception or a combination of a condom and spermicide).
- •Patient needs a total shoulder arthroplasty (humeral head and glenoid).
- •Patient has a diagnosis of primary osteoarthritis.
排除标准
- •Obstacles, which pose an inordinately high surgical risk, in the judgment of the certified surgeon.
- •Class IV or higher anesthetic risk.
- •Patient has a recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair the compliance with the study protocol.
- •Patient has had a shoulder fracture.
- •Patient had previous shoulder surgeries with the exception of an arthroscopic debridement procedure.
- •The patients has a massive rotator cuff tear (rupture >3 cm or total cicatrisation) demonstrated at time of the surgery that precludes the total shoulder replacement.
结局指标
主要结局
Change in Post-operative Radiographic Measurements of Prosthetic Relationships (Anteroposterior and Axillary x-rays)
时间窗: Up to 5 years postoperatively
Measurements include acromiohumeral interval, head to tuberosity distance, coracoid to glenohumeral joint distance, coracoid to tuberosity distance, humeral stem position (valgus/varus), humeral congruity and subluxation, glenoid comp version.
Change in Radiographic Analysis for Lucent Lines and Prosthesis Loosening
时间窗: Up to 5 year postoperatively
glenoid and humeral component lucency
Preoperative Radiographic Measurements of Standard Glenohumeral Relationships
时间窗: Up to 16 weeks prior to date of surgery
次要结局
- Change in Score on Short-Form 36 (SF-36)(Up to 5 years postoperatively.)
- Change in Score on EuroQOL (EQ-5D)(Up to 5 years postoperatively.)
- Change in Constant Score(Up to 5 years postoperatively.)
- Change in Range of Motion(Up to 5 years postoperatively.)
- Change in Total Score on Simple Shoulder Test (SST)(Up to 5 years postoperatively.)
- Change in ASES (American Shoulder and Elbow Surgeons) Score(Up to 5 years postoperatively.)