A Randomized Study of Non-Operative Management Versus Expedited Surgery Among WCB Patients With Small Rotator Cuff Tears: Affect Upon Time to Claim Closure in 2 Prairie Provinces
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Time to return to final work status
研究概览
简要总结
The overall goal of this proposed randomized study is to determine if surgery at the time of diagnosis or rehabilitation +/- surgery (i.e. surgery only when rehabilitation fails) results in shorter times to claim closure. The study will examine how often non-operative management is successful in resolving symptoms and allowing subjects to return to work without surgery. The investigators will also examine if there are subject, tear or work-related characteristics that affect the outcome of rehabilitation or expedited surgery and predict whether patients should be referred to operative or non-operative management at time of assessment. At study completion, the investigators expect to be able to definitively state the best management for subjects with these less serious RC tears.
The specific research questions to be addressed are as follows:
- In WCB subjects with high grade partial thickness (>50%) or small full thickness (≤ 1 cm.) rotator cuff tears, how does non-operative management (i.e. rehabilitation) or expedited surgery affect time to claim closure?
- Are there subject, tear or work-related characteristics that affect which patient management approach will be most effective and efficient?
详细描述
Design/Setting The present study will be a multi-center prospective, randomized controlled trial examining WCB patients presenting to Orthopaedic specialists for RC pathology.
Selection Criteria
Adult patients with an active WCB claim, presenting with a confirmed high-grade (>50%) partial-thickness or small (≤1cm) full-thickness RC tear, will be eligible for the study. Informed consent will be attained from WCB patients attending orthopaedic clinics in the Greater Edmonton and Greater Winnipeg areas. The complete list of inclusion/exclusion criteria is as follows:
Inclusion Criteria:
- Patient is over 18 years of age
- Patient has an active WCB Claim
- Patient has a high-grade (>50%) partial-thickness or small (<1cm) full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)
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
- None
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 is over 18 years of age
- •Patient has an active WCB Claim
- •Patient has a high-grade (>50%) partial-thickness or small (<1cm) full-thickness tear of the supraspinatus and/or infraspinatus, as confirmed by appropriate diagnostic imaging (MRI, Arthrogram, Ultrasound)
排除标准
- •Patient has a full-thickness tear of the subscapularis and/or teres minor
- •Patient has a low-grade (<50%) partial-thickness tear of the supraspinatus/infraspinatus
- •Patient has a moderate to large (>1cm) full-thickness tear of the supraspinatus/infraspinatus
- •Patient has undergone previous RC surgery to the affected shoulder
- •Patient has major joint trauma, infection, or avascular necrosis
- •Patient has chronic dislocation, inflammation, or degenerative glenohumeral arthropathy
- •Patient has evidence of significant cuff arthropathy (superior glenohumeral translation and/or acromial erosion, as diagnosed by diagnostic imaging)
- •Patient has a 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
- •Patient has a major medical illness where life expectancy is less than 2 years
- •Patient does not speak/read/understand English
- •Patient has no fixed address or means of contact
- •Patient unwilling to complete necessary follow-ups
结局指标
主要结局
Time to return to final work status
时间窗: Participations followed for duration of the study, up to 1 year, until they fully return to work
To answer our primary research question, time to return to work (in days) will be calculated. This will be defined as the interval from the date of orthopedic consultation/screening to final return to work status. We will also determine the time to any return to work status.
次要结局
- Demographics(1 year)
- Range of Motion(1 year)
- WORC Questionnaire(1 year)
- Orebro Questionnaire(1 year)
- Strength(1 year)
研究者
Dr. Peter MacDonald
Pan Am Clinic Medical Director and University of Manitoba Faculty of Medicine Professor
University of Manitoba