Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Single Assessment Numeric Evaluation (SANE)
研究概览
简要总结
To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. Patient's aged 18-80 years old with diagnosis of rotator cuff tear having failed non-operative management and being indicated for surgical intervention with use of suture anchors.
排除标准
- •Glenohumeral arthrosis
- •Previous shoulder surgery
- •Psychiatric diseasesMRI
- •Rheumatologic diseases
- •Fibromyalgia
- •Spine diseases
研究组 & 干预措施
Bone socket formation with a punch
suture anchor socket creation with punch
干预措施: suture anchor socket creation with punch (Procedure)
Bone socket formation with a drill
suture anchor socket creation with drill
干预措施: suture anchor socket creation with drill (Procedure)
结局指标
主要结局
Single Assessment Numeric Evaluation (SANE)
时间窗: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure. A SANE score requires the patient to rate their knee function on a scale of 0 to 100% with 100% being normal.
Visual Analogue Scale
时间窗: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form
时间窗: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
The PROMIS Physical Function Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate better physical function. Responses use a Likert scale: 1 = "Unable to do," 2 = "With much difficulty," 3 = "With some difficulty," 4 = "With a little difficulty," 5 = "Without any difficulty." Raw scores are summed and converted to T-scores. 50 = average function, 60 = 1 SD above (better), 40 = 1 SD below (worse).
PROMIS - Pain Interference
时间窗: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
The PROMIS Pain Interference Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate greater pain interference. Responses use a Likert scale: 1 = "Not at all," 2 = "A little bit," 3 = "Somewhat," 4 = "Quite a bit," 5 = "Very much." Raw scores are summed and converted to T-scores. 50 = average pain interference, 60 = 1 SD above (worse), 40 = 1 SD below (better).
次要结局
- Magnetic Resonance Imaging (MRI) of the Shoulder(2 weeks)
研究者
Matt Smith
ASSOCIATE PROFESSOR OF CLINICAL, MOI OUTPATIENT MEDICAL DIRECTOR, Orthopaedic Surgery
University of Missouri-Columbia