Arthroscopy-Assisted Lower Trapezius Transfer Using Long Head of Biceps Tendon Autograft as an Interposition Graft for Massive Irreparable Rotator Cuff Tears (LHBT)
The aim of the study is To evaluate the clinical, functional, and radiological outcomes of arthroscopically assisted lower trapezius tendon transfer using LHBT autograft as an interposition graft for massive irreparable rotator cuff tears., in terms of pain relief, shoulder range of motion, external rotation strength, patient-reported functional scores, and structural integrity of the transfer.
研究概览
地位
条件
详细说明
Massive rotator cuff tears represent a major cause of shoulder pain and disability among middle-aged and older patients. In younger, active patients with symptomatic massive irreparable tears, joint-preserving reconstructive procedures are generally favored over arthroplasty in order to maintain native anatomy and delay the need for prosthetic replacement. Tendon transfer of latissmus dorsi is preferered with autograft like Achillis tendon or semitendonosus tendon in this study we will use Long head of biceps tendon as interposition graft and evaluate the result clinicaly radiologicaly and functionaly postoperative
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Mahmoud M S Mahran, MD
- 电话号码:00201018882565
- 邮箱:mahmoudmahran408@gmail.com
研究联系人备份
- 姓名:Esraa S Kotb, Master
- 电话号码:01009595394
- 邮箱:Esraasayed845@gmail.com
学习地点
-
-
Asyut Governorate
-
Asyut、Asyut Governorate、埃及、71524
- Al-Azhar University Hospital, Assiut
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria :
- symptomatic massive posterosuperior rotator cuff tear (involving ≥2 tendons and/or ≥5 cm in the anteroposterior dimension) confirmed by MRI
- Tear confirmed intraoperatively as irreparable despite maximal mobilization (medialized footprint repair not feasible)
- Intact or repairable subscapularis tendon
- Intact deltoid muscle function
- Failure of at least 3-6 months of conservative treatment (physiotherapy, analgesics, activity modification) or prior failed rotator cuff repair
- Preoperative active or passive forward elevation ≥ 0°-30° (i.e., not a pseudoparalytic shoulder with fixed loss of elevation, per surgeon's assessment) - to be defined per the surgical team's operative criteria
- Available and functioning lower trapezius muscle and long head of biceps tendon on preoperative examination/imaging
- Patient willing and able to comply with the postoperative rehabilitation protocol and scheduled follow-up visits
Exclusion criteria :
- Advanced glenohumeral osteoarthritis (Hamada grade ≥ 3)
- Irreparable subscapularis tear or anterosuperior tear pattern
- Deltoid dysfunction, paralysis, or previous deltoid detachment
- Lower trapezius dysfunction, atrophy, or prior denervation (e.g., spinal accessory nerve injury)
- Long head of biceps tendon absent, previously ruptured, or already tenotomized/tenodesed
- Axillary nerve palsy or brachial plexus injury
- Active glenohumeral or periprosthetic infection
- Uncontrolled systemic disease precluding surgery (e.g., uncontrolled diabetes mellitus, severe cardiopulmonary disease)
- Inflammatory arthropathy of the shoulder
- Previous ipsilateral shoulder arthroplasty
- Patients unable or unwilling to give informed consent or to comply with follow-up
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 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 |
|---|---|
|
实验性的:Long head of biceps tendon autograft
We asses the outcomes of Arthroscopy-Assisted Lower Trapezius Transfer Using Long Head of Biceps Tendon Autograft as an Interposition Graft for Massive Irreparable Rotator Cuff Tears |
Arthroscopy-Assisted Lower Trapezius Transfer Using Long Head of Biceps Tendon Autograft as an Interposition Graft for Massive Irreparable Rotator Cuff Tears |
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 |
|---|---|---|
|
change in Constant-Murley Shoulder Score
大体时间:6 weeks, 3, 6,9,months and 1 year
|
The Constant-Murley Shoulder Score (CMS) is a 100-point combined subjective and objective scoring system designed to assess overall shoulder function: Maximum Score: 100 points (indicates best possible shoulder function) Minimum Score: 0 points (indicates severe limitation/impairment) |
6 weeks, 3, 6,9,months and 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Visual analog score VAS
大体时间:6 weeks, 3, 6,9,months and 1 year
|
psychometric response scale used to measure subjective pain intensity, including shoulder pain: Standard Format: A 10 cm (100 mm) horizontal line anchored by two extreme descriptors at each end: 0 cm (0 mm): "No pain" 10 cm (100 mm): "Worst imaginable pain" (or "Worst pain ever felt") |
6 weeks, 3, 6,9,months and 1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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
与本研究相关的术语
其他研究编号
- Azhar university Assiut
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Data will be available with a corresponding offer on reasonable request
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.