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临床试验/NCT04458025
NCT04458025Unknown不适用

Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.

Borja Alcobía-Díaz MD, PhD0 个研究点目标入组 64 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
64
主要终点
Functionality

研究概览

简要总结

Arthroscopic suture for complete and partial >50% thickness Rotator Cuff Tears (RCT) is the gold standard. However, there is no evidence of superiority of delayed postoperative mobilization protocols versus early ones, in terms of ROM, pain, quality of life and complications in last review published in 2019 by AAOS. Although, excessive immobilization can lead into stiffness, neuropathic pain or adhesive capsulitis. All of these are complications which can diminish patient quality of life or prolong their return to work or sports activities.

This is an experimental, prospective, non-blind, comparative, randomized clinical trial, between two options of treatment. On one treatment branch, we will continue applying our standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation. On the other treatment branch, we will start passive mobilization during second week after surgery, including controlled external rotation movements. All recruited patients will be followed-up during 12 months.

Our main objective is to compare differences in terms of functionality (using ASES scale). Secondary objectives are to compare differences in terms of ROM, functionality (using CMS and UCLA scales), pain (using VAS score), need of analgesic drugs, quality of life (using EQ-5D scale), return to previous work and sports activities, patient adhesion to protocol, complications and MRI rotator cuff retear ratio at 12 months follow-up.

After this study, we hope to develop a new postoperative mobilization protocol for patients. This protocol will be focused on timing, and self-administrated exercises in order to involve patients in their recovery, in the fastest and safest way for them.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: Less tan 70 years old.
  • Sex: Male or Female.
  • Treatment: Arthroscopic RCT suture.
  • RCT type: Degenerative, total or partial >50% thickness, less than 3 cm length tear.
  • MRI Tear Classification: Patté's in coronal view I or II, Goutalier's <2, Fukuda's <2 and Seebauer´s 1A maximum.

排除标准

  • Not meet the inclusion criteria.
  • Previous surgical procedure in affected shoulder.
  • Have been treated with 2 or more glucocorticoid injections in last year.
  • High anesthetic risk.

结局指标

主要结局

Functionality

时间窗: 12 months after surgery

Functionality assessment using ASES scale

次要结局

  • Functionality-Constant-Murley scale(12 months after surgery)
  • Pain(12 months after surgery)
  • Functionality-UCLA(12 months after surgery)
  • Analgesic use(12 months after surgery)
  • Complications(12 months after surgery)
  • MRI rotator cuff retear ratio(12 months after surgery)
  • Range of motion(12 months after surgery)
  • Quality of life(12 months after surgery)

研究者

发起方
Borja Alcobía-Díaz MD, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Borja Alcobía-Díaz MD, PhD

MD, PhD

Hospital San Carlos, Madrid

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