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

Borja Alcobía-Díaz MD, PhD

Status: Unknown

Conditions: Rotator Cuff Tear Repair

Treatments: Other: Early rehabilitation program; Other: Standard rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT04458025

RAPIDREHAB

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Standard rehabilitation program

Active Comparator group

Description:

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

Treatment:

Other: Standard rehabilitation program

Early rehabilitation program

Experimental group

Description:

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

Treatment:

Other: Early rehabilitation program