The Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique (Knotless2)
Pilot Study on the Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique
Arthroscopic repairs of rotator cuff tears are now predominantly performed using double-row anchor and suture techniques. This approach is considered to have superior biomechanics compared to previous single-row repair techniques. Numerous double-row techniques with a knotted medial row have been described, but a consensus regarding their performance has yet to be established. One such technique is effective and easily reproducible: the "double-row Montgolfier" arthroscopic repair technique. This knotless approach features a uniformly distributed, load-sharing, and radially oriented suture configuration, much like the envelope cables of a Montgolfier hot air balloon, its namesake. Other advantages include the possibility of applying progressive manual tension to each suture and easy intraoperative adjustments based on the size, shape, and delamination of the tear, as well as the tension and quality of the tissues. Future studies are needed to validate the biomechanics and clinical outcomes of this technique. To date, only one publication describes this technique, from which its practice is gradually developing in France. No studies currently evaluate the performance of this approach. This pilot study will provide data to inform the design of other studies.
The main objective of this study is to evaluate the clinical results (functional and pain) of the "Montgolfier Double-Row Knotless" technique at 12 months of follow-up.
研究概览
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:Jean-François Oudet, M.
- 电话号码:0033683346567
- 邮箱:jf.oudet@ecten.eu
学习地点
-
-
-
Lyon、法国、69008
- Hôpital privé Jean Mermoz
-
接触:
- Lionel Neyton, Dr
- 电话号码:0033 0437530057
- 邮箱:neyton.lionel@orange.fr
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male or female patient aged over 18,
- Patient scheduled for rotator cuff repair using the Montgolfier double-row technique,
- Patient affiliated with or a beneficiary of a social security scheme,
- Patient who has been informed and has provided free, informed, and written consent.
Exclusion Criteria:
- Patient who has previously undergone shoulder surgery
- Patient with a shoulder condition resulting from a workplace accident or suffering from an occupational disease
- Patients lacking the intellectual or physical capacity to provide consent
- Protected patient: adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision; or under judicial protection
- Pregnant, breastfeeding, or recently delivered woman
- Patient hospitalized without consent.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 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:Patient scheduled for rotator cuff repair using the Montgolfier double-row technique.
|
Rotator cuff repair using the Montgolfier double-row technique.
Ultrasound at 6 months and one year after surgery
Questionnaires :
|
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 |
|---|---|---|
|
Achievement of the MCID (Minimal Clinically Important Difference) for the ASES (American Shoulder and Elbow Surgeons) score at 12 months.
大体时间:between day 0 and 12 months
|
For each patient, the change in the ASES score between day 0 and 12 months will be calculated.
The patient will be considered successful if this change is greater than or equal to 27.1 (MCID of the ASES score).
|
between day 0 and 12 months
|
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
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.