Comparison of Postoperative Sling Use in Patient Outcomes After Isolated Biceps Tenodesis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percent of Complications As Measured by Medical Records
研究概览
简要总结
The purpose of this study is to evaluate whether the use of a sling after surgery (biceps tenodesis) is required in recovery and rehabilitation. Biceps tenodesis is one of the most common surgeries for patients who have biceps tendon inflammation and/or instability, rotator cuff tears, and labral tears that do not get better with medications or physical therapy. A biceps tenodesis involves cutting the biceps tendon and reconnecting it to the shoulder with sutures or metal screws. After surgery, most patients are required to wear a shoulder sling and limit certain arm motions to protect the healing tendon. A recent study found using a more flexible rehabilitation protocol for biceps tenodesis did not change outcomes (strength or range-of-motion) and allows patients to return to some regular activities earlier. This data suggests patients may not need to wear a sling after surgery. Therefore, this study aims to evaluate this.
This study will have two groups-one that continues to wear the sling, and one that does not. Patients will be randomly assigned to one of these groups. At each follow-up visit after surgery, shoulder strength and range-of-motion will be measured and several surveys about shoulder function will be completed. These surveys will provide information to compare between both groups. If assigned to the group that wears the sling, patients will record how often they are wearing the sling in a paper diary/log. Additionally, at the 6-month follow-up, an ultrasound will be obtained to make sure the tendon is healing properly regardless of which group patients are assigned to. Finally, medical history will be collected to identify protective and risk factors for any differences that might be found.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo open or arthroscopic isolated BT for diagnoses including but not limited to biceps tendinitis or tenosynovitis, biceps tendon tears, partial-thickness rotator cuff tears, subacromial bursitis, superior labrum from anterior to posterior (SLAP) tear, biceps instability
- •Patients with minimum 6-month follow-up
排除标准
- •Patients who undergo any concomitant procedures necessitating ROM restrictions, including but not limited to rotator cuff repair, labral repair, SLAP lesion repair, or shoulder arthroplasty
- •Patients with history of prior ipsilateral proximal biceps procedures
- •Patients with history of conditions resulting in severe shoulder strength and ROM limitations (e.g. severe degenerative glenohumeral osteoarthritis, polymyalgia rheumatica, cervical radiculopathy, significant muscle paralysis, etc.)
结局指标
主要结局
Percent of Complications As Measured by Medical Records
时间窗: Up to 2 years
Degrees of Range-of-Motion As Measured by Physical Exam
时间窗: Up to 30 minutes
Strength as Measured by Physical Exam
时间窗: Up to 30 minutes
Strength is measured on a 5-point scale with 0 being no discernible muscle contraction and 5 being muscle contraction and maximum resistance
次要结局
- Pain as Measured by the Visual Analog Scale(Up to 5 minutes)
- Shoulder Function as Measured by the Simple Shoulder Test (SST)(Up to 15 minutes)
- Shoulder Function as Measured by Constant Murley Score (CMS)(Up to 15 minutes)
- Shoulder Function as Measured by the Single Assessment Numeric Evaluation (SANE)(Up to 5 minutes)
- Shoulder Function as Measured by the American Shoulder and Elbow Surgeons (ASES)(Up to 15 minutes)
- Percent of Patients Satisfied as Measured by Patient Survey(Up to 5 minutes)
- Shoulder Function as Measured by the Western Ontario Rotator Cuff (WORC) Index(Up to 15 minutes)
研究者
Michael Karns, MD.
Assistant Professor
University Hospitals Cleveland Medical Center