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

NCT ID: NCT04458025

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-12-31

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.

Conditions

Rotator Cuff Tear Repair

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard rehabilitation program

Standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation

Group Type: ACTIVE_COMPARATOR

Standard rehabilitation program

Intervention Type: OTHER

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

Early rehabilitation program

Early rehabilitation program will start passive mobilization during second week after surgery, including controlled external rotation movements

Group Type: EXPERIMENTAL

Early rehabilitation program

Intervention Type: OTHER

Early rehabilitation program will start 2 weeks

Interventions

Standard rehabilitation program

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

Intervention Type: OTHER

Early rehabilitation program

Early rehabilitation program will start 2 weeks

Intervention Type: OTHER

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.

• Previous surgical procedure in affected shoulder.
• Have been treated with 2 or more glucocorticoid injections in last year.
• High anesthetic risk.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Borja Alcobía-Díaz MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Borja Alcobía-Díaz MD, PhD

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Borja Alcobía Díaz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico San Carlos

Central Contacts

Borja Alcobía Díaz, MD PhD

Role: CONTACT

balcobiadiaz@gmail.com

913303638

Other Identifiers

RAPIDREHAB

Identifier Type: -

Identifier Source: org_study_id