Rotator Cuff Injury to Surgery (RC-IS)
Effect of Surgical Wait Times on Outcomes of Rotator Cuff Surgery
研究概览
详细说明
Consented patients will undergo a pre-operative assessment conducted by a study physiotherapist, including the following: 1) demographic information (age, gender, height, weight, smoking status, employment, recreational activities, time of injury, etc.); 2) shoulder ROM, 3) shoulder strength using a handheld dynamometer, and 4) subjective shoulder-specific outcome measures which include the Western Ontario Rotator Cuff Score (WORC), American Shoulder and Elbow Score (ASES), and Simple Shoulder Test (SST). Measurement of tear size will also be documented by an experienced radiologist from the initial MRI or ultrasound.
Patients will undergo initial consultation with the orthopaedic surgeon to confirm suitability for surgical management. If deemed appropriate to continue as a participant, the individual participants will be randomized to one of the two study groups. If in the Expedited group, the patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sports medicine physician. If randomized to the Control or 'Typical Wait Time' Group, surgery will take place no earlier than 9 months and no later than 12 months after the sports medicine physician consult.
Just prior to surgery, a second diagnostic imaging test will take place, either ultrasound or MRI, to document progress in tear size and any secondary pathology in the control group. Diagnostic test findings will be confirmed intraoperatively. All rotator cuff repairs will be performed by one of four fellowship trained orthopaedic surgeons.
The control study group will be sent the subjective questionnaires at 8 week intervals while they are waiting for surgery. Post-surgery study follow-ups will take place at 6, 12, and 24 months for both groups. All patients will be provided with the same rehabilitation protocol including pain management, range of motion and strengthening exercises. The same data as that collected pre-surgery will be repeated as well as any occurrences of failure of the repair. Failure of the repair is defined as ongoing severe pain, limited ROM, and/or decreased strength. If a failure occurs, follow-ups will continue until 24 months following failure or 24 months following revision surgery, if performed.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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Manitoba
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Winnipeg、Manitoba、加拿大、R3M3E4
- Pan Am Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Between the ages of 45 and 70 years old
- Acute full-thickness rotator cuff tear of supraspinatus an/or infraspinatus (as confirmed by appropriate diagnostic imagine)
Exclusion Criteria:
- Presence of a tear of the subscapularis and/or teres minor;
- Presence of a partial-thickness tear of the supraspinatus/infraspinatus;
- Patient has undergone previous RC surgery to the affected shoulder;
- Patient has an active WCB Claim or prior claim related to their shoulder;
- Previous major joint trauma, infection, or avascular necrosis;
- Chronic dislocation, inflammation, or degenerative glenohumeral arthropathy;
- Evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
- Psychiatric illness, cognitive impairment, or other health condition (i.e. visual impairment) which precludes informed consent or renders the patient unable to complete study questionnaires
- Major medical illness where life expectancy is less than 2 years;
- Does not speak/read/understand English;
- No fixed address or means of contact;
- Unwillingness to complete necessary follow-ups
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Early Surgery
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Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.
|
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实验性的:Regular Wait Time
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Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Western Ontario Rotator Cuff
大体时间:24 months
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WORC score questionnaire is a tool designed for self-assessment of shoulder function for patients with rotator cuff problems.
Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate
|
24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES)
大体时间:24 months
|
The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function.
Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate
|
24 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Injury to Surgery Time
大体时间:24 months
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Time will be calculated from initial injury to consultation to surgery.
|
24 months
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合作者和调查者
赞助
调查人员
- 首席研究员:Jeff Leiter, MSc, PhD、Pan Am Clinic
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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