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Clinical Trials/NCT04458025
NCT04458025
Unknown
Not Applicable

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

Borja Alcobía-Díaz MD, PhD0 sites64 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Tear Repair
Sponsor
Borja Alcobía-Díaz MD, PhD
Enrollment
64
Primary Endpoint
Functionality
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 31, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Borja Alcobía-Díaz MD, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Borja Alcobía-Díaz MD, PhD

MD, PhD

Hospital San Carlos, Madrid

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Functionality

Time Frame: 12 months after surgery

Functionality assessment using ASES scale

Secondary Outcomes

  • 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)

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