Pilot Study on the Clinical and Ultrasound Outcomes of Double-row "Knotless" Rotator Cuff Repairs Using the Montgolfier Technique
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Achievement of the MCID (Minimal Clinically Important Difference) for the ASES (American Shoulder and Elbow Surgeons) score at 12 months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patient scheduled for rotator cuff repair using the Montgolfier double-row technique.
干预措施: Rotator cuff repair (Procedure)
Patient scheduled for rotator cuff repair using the Montgolfier double-row technique.
干预措施: ultrasound (Procedure)
Patient scheduled for rotator cuff repair using the Montgolfier double-row technique.
干预措施: Questionnaires (Other)
结局指标
主要结局
Achievement of the MCID (Minimal Clinically Important Difference) for the ASES (American Shoulder and Elbow Surgeons) score at 12 months.
时间窗: 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).
次要结局
未报告次要终点