Study Evaluating Reverse Versus Anatomic Total Shoulder Arthroplasty in Shoulders With Greater Than 15 Degrees of Retroversion 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
- 1
- 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) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a prospective, randomized controlled trial to determine the optimal treatment in this patient population.
详细描述
Osteoarthritis (OA) of the shoulder or glenohumeral joint, 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 our aging population. Total shoulder arthroplasty (TSA) or Reverse shoulder arthroplasty (RSA) are common surgical procedures used to treat patients with glenohumeral OA. TSA involves replacing the worn-out ball and socket glenohumeral joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent, particularly when the OA is associated with bone erosion on the glenoid (socket). An additional surgical technique using an "augmented glenoid component" has been developed to address this issue of missing bone. This technique attempts to realign and restore balance to the shoulder joint using artificial components and is also being performed as standard of care.
RSA is an alternative surgical procedure 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 in older population and those with a more advanced level of OA degeneration. Previous studies have been limited to case series with small sample sizes and respective designs.
This research will provide surgeons with new information regarding the best treatment for this patient population.
This randomized controlled trial (RCT) will compare TSA + augmented glenoid component and RSA procedures to determine which approach produces better functional outcomes and quality of life in those with advanced OA who are in older patient population (65 years and older).
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 (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
- •Diagnosis of idiopathic shoulder OA.
- •Patients who have failed standard non-surgical management of their shoulder OA 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 at least 6 months. Medical management will be defined as: a) The use of drugs including analgesics and nonsteroidal anti-inflammatory drugs, b) Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.), c) Activity modification
- •Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
- •Patients with a glenoid deficiency and >15 degrees of glenoid retroversion up to a maximum of 26 degrees of glenoid retroversion (i.e. -15.1, -17, -20…etc.)
- •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
- •Rheumatoid arthritis in the affected shoulder
研究组 & 干预措施
Total Shoulder Arthroplasty (anatomic) + augmented glenoid component
TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. An additional surgical technique, "augmented glenoid component" implantation is performed when there is missing bone in the shoulder and is currently being done as standard of care. This technique is used particularly when a large amount of instability within the shoulder joint is present. This technique attempts to realign and restore balance to the shoulder joint using artificial components.
干预措施: Total Shoulder Arthroplasty + augmented glenoid component (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: 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.
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
时间窗: 24-Months 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
- EuroQol EQ-5D-5L(5-Years Post-Operative)
- Pain Level(5-Years Post-Operative)
- Subjective Shoulder Value(5-Years Post-Operative)
- Standard CT Scans(5-Years Post-Operative)
- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)(5-Years Post-Operative)
- Constant Score(5-Years Post-Operative)
- Adverse Events (AE) and Serious Adverse Events (SAE)(5-Years Post-Operative)
- Health Care Utilization(5-Years Post-Operative)
- Standard CT Scans(24-Months Post-Operative)
- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)(24-Months Post-Operative)
- Pain Level(24-Months Post-Operative)
- Subjective Shoulder Value(24-Months Post-Operative)
- EuroQol EQ-5D-5L(24-Months Post-Operative)
- Constant Score(24-Months Post-Operative)