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

NCT04458025 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-07-07

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tear Repair

Interventions

OTHER

Standard rehabilitation program

Standard rehabilitation will start 4 weeks after surgery according to the standard of cre

OTHER

Early rehabilitation program

Early rehabilitation program will start 2 weeks

Sponsors & Collaborators

  • Borja Alcobía-Díaz MD, PhD

    lead OTHER

Principal Investigators

  • Borja Alcobía Díaz, MD PhD · Hospital Clinico San Carlos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-09-30
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04458025 on ClinicalTrials.gov