Influence of Intraoperative Repair Tension on Postoperative Healing of Full-thickness Rotator Cuff Tears
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Tendon tension
研究概览
简要总结
Relevant problems of rotator cuff repair:
- High retear rate after rotator cuff repair of 13%, despite regard of the criteria for "reparability" of a tear.
- Long and exhausting rehabilitation after rotator cuff repair with an abduction splint for six weeks.
Hypothesis:
The investigators believe that high tension repair has a higher retear rate than low tension repair, regardless of the tear size. The investigators also believe that abduction of the arm can reduce relevant tension on the repair. But not each repair benefits equally from this.
Relevance of this hypothesis:
The ingenious advantage of this new parameter (intraoperative repair tension) is, that it can be influenced. In future, if this hypothesis would be true, the repair tension could be reduced intraoperative by release, side-to-side (margin convergence) repair or medialization of the footprint and thereby convert a high risk to a low risk tension repair.
Moreover, it could be that patients with a low tension repair does not necessarily have to wear an abduction splint. And on the other hand, high tension repair patients should probably wear the abduction splint longer with gradually reduction.
Approach:
The present research plan focused on a new intraoperative (arthroscopic) determinable parameter ("repair tension" on footprint in 0° and 40° abduction) to determine the risk of recurrence after tendon repair in rotator cuff tears, which are pre- and intraoperative defined as "reparable". Therefore, the tension of the repaired tendon is measured intraoperative with a spring balance (newtonmeter) and correlated with the postoperative retear-rate.
• Measure intraoperative repair tension with the arm in 0° and 40° of abduction
详细描述
How the investigators plan the study:
This is a prospective clinical study, risk category A. It is one-armed (all participants have the same procedure/rehabilitation) and single-blinded (participants doesn't knows the repair tension).
The investigators are an orthopaedic clinic in Zurich (Universitätsklinik Balgrist, Zürich) with about 250 arthroscopic rotator cuff repairs per year. Our plan is to recruit at least 100 participants in a year for this prospective clinical study. The participants have to fulfill the inclusion criterions. The diagnosis for the rotator cuff tears are made on the basis of arthro-MRI scans. The investigators do the operations in our clinic. The entire follow-up is one year for each participant. We plan three regular postoperative consultations. The tendon healing is controlled postoperative by ultrasound (six weeks and 4 month postoperative) and by MRI (one year postoperative).
Visit 0: participant recruitment:
The participants who are suitable for the study, will be recruited in the clinic for the study. They are aware of the essential information and the process and have 14 days time to read the information paper.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Signed informed consent
- •Male/female from 18-99 years
- •All arthroscopic reparable transmural supra-/infraspinatus tears
- •German speaking
排除标准
- •Previous operation on the ipsilateral rotator cuff
- •Irreparable rotator cuff tear (supra- and / or infraspinatus and / or subscapularis)
- •static antero-superior subluxation of humeral head
- •dynamic antero-superior subluxation of humeral head
- •pseudoparalysis for anteflexion, hornblow sign, dropping- arm sign
- •fatty infiltration goutallier 3-4 (MRI)
- •reduced acromiohumeral distance <7mm (RX)
- •intraoperative not reparable
- •Mild/severe osteoarthritis (RX, Hamada II-IV)
- •Inability of patient (language problems, mental illness, dementia)
结局指标
主要结局
Tendon tension
时间窗: during surgery
Measuring tendon Tension according to the footprint in 0° and 45° abduction with a Newtonmeter.
次要结局
- Rotator cuff re-tear(one year)