Study Evaluating Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
研究概览
简要总结
This study will compare total shoulder arthroplasty (TSA) reverse shoulder arthroplasty (RSA) procedures, in the context of a prospective, randomized-controlled trial to determine the optimal treatment in patients 65 years of age and older, and equal to or less than 15 degrees of glenoid retroversion, who have glenohumeral osteoarthritis.
详细描述
Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can be the cause of pain and dysfunction and is a growing occurrence in the investigator's aging population. TSA or RSA are common surgical procedures used to treat patients with shoulder OA. TSA is able to keep the "natural anatomy" of the shoulder and involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent, particularly when the arthritis is associated with bone erosion on the glenoid (socket).
RSA is an alternative surgical procedure commonly used and involves replacing and reversing the ball and the socket (i.e. opposite of TSA). RSA is typically performed in patients with a rotator cuff deficiency and more severe OA. Though RSA procedures show marked increase in clinical and functional outcomes, evidence of its long-term results are sparse, and as such is typically reserved for when treating an older patient population.
Few research studies have compared these different surgical techniques to one another, in the older patient population.
This research will provide surgeons with new information regarding the best treatment for patients in this population.
This Randomized Controlled Trial (RCT) will compare TSA and RSA procedures in those 65 years of age and older, who have equal to or less than 15 degrees of glenoid retroversion, in an effort to determine which approach produces better functional outcomes and improved quality of life in this patient population.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have failed standard non-surgical management of their idiopathic shoulder osteoarthritis who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months. Medical management will be defined as:
- •The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
- •Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
- •Activity modification
- •Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
- •Patients may present with a glenoid deficiency and </=15 degrees of retroversion
- •65 years of age and older
排除标准
- •Active joint or systemic infection
- •Rotator cuff arthropathy
- •Significant muscle paralysis
- •Charcot's arthropathy
- •Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
- •Unable to understand the consent form/process
- •Psychiatric illness that precludes informed consent
- •Unwilling to be followed for the duration of the study
- •Retroversion cannot be surgically corrected to within 10 degrees of neutral
- •History of previous shoulder surgery on affected side
研究组 & 干预措施
Total Shoulder Arthroplasty (anatomic)
TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components.
干预措施: Total Shoulder Arthroplasty (Procedure)
Reverse Shoulder Arthroplasty
RSA procedure is similar to a TSA, however the orientation of the ball and socket joint is placed in the reverse position
干预措施: Reverse Shoulder Arthroplasty (Procedure)
结局指标
主要结局
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
时间窗: 24-Months and 5-Years Post-Operative
The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
次要结局
- Pain Level(24-Months and 5-Years Post-Operative)
- Subjective Shoulder Value(24-Months and 5-Years Post-Operative)
- Standard CT Scans(24-Months and 5-Years Post-Operative)
- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)(24-Months and 5-Years Post-Operative)
- EuroQol EQ-5D-5L(24-Months and 5-Years Post-Operative)
- Adverse Events (AE) and Serious Adverse Events (SAE)(24-Months and 5-Years Post-Operative)
- Constant Score(24-Months and 5-Years Post-Operative)
- Health Care Utilization(24-Months and 5-Years Post-Operative)