Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: A Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Change in Western Ontario Osteoarthritis of the Shoulder (WOOS)
研究概览
简要总结
Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide and it is common in an aging population. Surgical shoulder replacement (arthroplasty) is typically considered when non-surgical measures, such as physiotherapy or medication, have failed. There are two commonly performed surgical replacement procedures in patients who have advanced shoulder OA, and are 65 years of age and older: "Total Shoulder replacement or Arthroplasty (TSA)" and "Reverse Total Shoulder Arthroplasty (RTSA)".
Few studies have compared the two procedures. Surgeons face uncertainty regarding which procedure to perform in patients 65 years of age and older. This pilot Randomized Controlled Trial (RCT) will compare the "TSA" and "RTSA" procedures, in patients 65 years of age and older. Participants will be assigned at random, (like flipping a coin), to one of the two groups (TSA or RTSA). The overall goal of this pilot study is to determine which procedure produces better functional and quality of life outcomes with fewer complications within the first 12-months after surgery. Moreover, pilot data will help determining the feasibility of conducting a larger trial comparing TSA versus RTSA surgical management in 65 years of age and older participants with advanced shoulder OA.
详细描述
- Statement of objectives
Primary objective: To compare clinical and health related quality of life (HRQL) outcomes of Total Shoulder Arthroplasty (TSA) or Reverse Total Shoulder Arthroplasty (RTSA) management in 65 years of age and older patients with advanced shoulder osteoarthristis (OA) over the first 12-months post-surgery.
Secondary objective: To determine the feasibility of conducting a definitive randomized control trial (RCT) comparing TSA versus RTSA surgical management in 65 years of age and older patients with advanced shoulder OA. 2. Background, Rationale, and Present state of Knowledge
Shoulder OA is common in aging population and may substantially impact quality of life.1-3 Seniors older than 65 years may surpass 2 billion by 20504 increasing the impact of chronic conditions such as OA on both health services and society.5 Patients with OA who do not respond to non-operative management usually require shoulder arthroplasty such as TSA and RTSA.3
TSA is considered the gold standard treatment for younger patients with advanced shoulder OA, intact rotator cuff and preserved glenoid bone stock.6 However, for patients older than age 65 years with an intact rotator cuff (RC), optimal management is unclear. Even though RC muscles may be preserved at time of TSA, RC pathology increases with age.9 Further, RC dysfunction has been linked to increased numbers of TSA failures.10-12 Young et al.10 found that secondary RC dysfunction developed in a significant number of participants undergoing TSA and was associated with worse clinical and radiographic outcomes.10 Melis et al.11 reported 65% of patients undergoing revision TSA had associated RC tears at time of revision surgery. Chronic secondary RC pathology is seen in 55% of patients who retained their implants after TSA for over 15 years.12 The available evidence regarding outcomes after TSA compared to RTSA is mostly based on non-randomized cohort studies and may pose some challenges in interpreting the data, due to variation in patient characteristics and surgeon preference.
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)
盲法说明
Participants and outcome assessors will be blinded to group allocation. The surgeons will use a Research Electronic Data Capture (REDCap) software to randomize the participant. REDCap is password protected and only accessibly for research personnel. The outcome assessors will not have access to the randomization information in REDCap which will maintain blinding to participant group allocation. Surgeons will not informe participant about procedure received until the end of last follow-up.
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 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 gleno-humeral 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
- •Need for an augmented glenoid component or a bone graft to correct version to within 10 degrees of neutral
- •Retroversion cannot be surgically corrected to within 10 degrees of neutral with a "high- side" ream technique
- •Significant muscle paralysis
- •Charcot's arthropathy
- •Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
- •Active Workers Compensation Board (WCB) claim
- •Unable to understand the consent form/process
- •Psychiatric illness that precludes informed consent
- •Unwilling to be followed for the duration of the study
- •History of previous shoulder surgery on affected side
研究组 & 干预措施
Reverse Total Shoulder Arthroplasty (RTSA)
Patient will undergo a RTSA as per standard technique. It uses a stemmed metal humeral component attached to the glenoid and the shallow glenoid component attached to the humerus. Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within < 10 degrees of neutral glenoid version. Standard instruments including a spherical burr and power reamers will be used to achieve this.
干预措施: Reverse Total Shoulder Arthroplasty (RTSA) (Procedure)
Total Shoulder Arthroplasty (TSA)
Patients will undergo standard glenoid preparation and implantation of a TSA. It uses a stemmed metal humeral component to replace the arthritic head of humerus and a shallow polyethylene glenoid component to replace the arthritic glenoid surface. The degree of anterior- reaming will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.
干预措施: Total Shoulder Arthroplasty (TSA) (Procedure)
结局指标
主要结局
Change in Western Ontario Osteoarthritis of the Shoulder (WOOS)
时间窗: Baseline, 6 weeks, 3-, 6- and 12-months
WOOS is a valid, reliable and responsive 19-item self-administered questionnaire that assesses health-related quality of life in patients with osteoathritis undergoing arthroplasty. It consists of 4 domains: pain and physical symptoms; sports, recreation, and work; lifestyle function; and emotional function. The score ranges from 0 to 1,900, with a higher raw score corresponding with the worse outcome.
次要结局
- Change in Shoulder Pain(Baseline, 6 weeks, 3-, 6- and 12-months)
- Number of complications(6 weeks, 3-, 6- and 12-months)
- Number of re-operations(6 weeks, 3-, 6- and 12-months)
- Change in Shoulder Range of Motion (ROM)(Baseline, 6 weeks, 3-, 6- and 12-months)
- Change in The American Shoulder and Elbow Surgeon's (ASES) questionnaire(Baseline, 6 weeks, 3-, 6- and 12-months)
- Change in EuroQol EQ-5D-5L quality of life questionnaire(Baseline, 6 weeks, 3-, 6- and 12-months)
- Number of re-admissions(6 weeks, 3-, 6- and 12-months)
- Change in Shoulder Strength(Baseline, 6- and 12-months)
- Change in Constant Score(Baseline, 6- and 12-months)
- Change in Subjective Shoulder Value (SSV)(Baseline, 6 weeks, 3-, 6- and 12-months)