Comparison of Bicep Tendon Migration Between Two Techniques for Open Subpectoral Biceps Tenodesis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Sterile radiolucent bead location distance
研究概览
简要总结
Participants who are indicated for an open biceps tenodesis procedure will be recruited to join the study. The participant will undergo the standard biceps tenodesis procedure using either one standard anchor or two mini anchors by the study staff surgeon. Both techniques are safe and considered standard of care. The participant will be randomized to either group. After the biceps are secured in the standard fashion, a sterile radiolucent bead will be applied to the tendon. The participant will undergo xray imaging in the post-anesthesia care unit to determine a baseline measurement of the location of the radiolucent bead. The participant will then undergo further xray imaging at their 2 week and 6 month-up visits.
详细描述
Participants who are indicated for an open biceps tenodesis procedure will be recruited to join the study. The participant will undergo the standard biceps tenodesis procedure using either one standard anchor or two mini anchors by the study staff surgeon. Both techniques are safe and considered standard of care. The participant will be randomized to either group. After the biceps are secured in the standard fashion, a sterile radiolucent bead will be applied to the tendon. This will allow for measurements to be made on xray imaging in the post-operative period. The placement of the clip is the only experimental portion of the procedure. The participant will undergo xray imaging in the post-anesthesia care unit to determine a baseline measurement of the location of the radiolucent bead. The participant will then undergo further xray imaging at their 2 week and 6 month-up visits. These visits are standard visits for the participant who undergo this procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant age 18 and above who would otherwise indicated for biceps tenodesis due to biceps tendinopathy with or without associated rotator cuff pathology
排除标准
- •Participant under the age of 18 will be excluded from the study as there is no indication to perform this procedure in children.
- •Any participant who had previous surgery or injury to their biceps or biceps tendon will be excluded.
研究组 & 干预措施
Two Mini Anchors
Participant will receive two mini anchors during standard biceps tenodesis procedure
干预措施: Two Mini Anchors (Procedure)
One Anchor
Participant will receive one standard anchor during standard biceps tenodesis procedure
干预措施: One Anchor (Procedure)
结局指标
主要结局
Sterile radiolucent bead location distance
时间窗: Baseline, 2-weeks, 6-months
Sterile radiolucent bead location will be measured during all 3 xrays. Comparison of these measurements will be between the two groups.
次要结局
- Participant Reported Outcome VAS(2-weeks, 6-months)
- Participant Reported Outcome Constant(2-weeks, 6-months)
- Participant Reported Outcome ASES(2-weeks, 6-months)
- Participant Reported Outcome SSV(2-weeks, 6-months)
研究者
Michael T. Freehill
Associate Professor
Stanford University