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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tear Repair
• Intervention / Treatment: Other: Standard rehabilitation program; Other: Early rehabilitation program

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Borja Alcobía Díaz, MD PhD; Phone Number: 913303638; Email: balcobiadiaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard rehabilitation program; Standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation	Other: Standard rehabilitation program; Standard rehabilitation will start 4 weeks after surgery according to the standard of cre
Experimental: Early rehabilitation program; Early rehabilitation program will start passive mobilization during second week after surgery, including controlled external rotation movements	Other: Early rehabilitation program; Early rehabilitation program will start 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality	Functionality assessment using ASES scale	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality-Constant-Murley scale	Functionality assessment using Constant-Murley scale	12 months after surgery
Functionality-UCLA	Functionality assessment using UCLA scale	12 months after surgery
Pain	Pain estimation according to visual analogic scale	12 months after surgery
Range of motion	Range of motion measured in degrees of a circle	12 months after surgery
Analgesic use	Need of analgesic drugs during the follow up period	12 months after surgery
Quality of life	Quality of life according to EQ-5D scale	12 months after surgery
Complications	Complications related to the surgery or rehabilitation	12 months after surgery
MRI rotator cuff retear ratio	MRI rotator cuff retear ratio determinate by MRI	12 months after surgery

Collaborators and Investigators

• Sponsor: Borja Alcobía-Díaz MD, PhD
• Investigators: Principal Investigator: Borja Alcobía Díaz, MD PhD, Hospital Clinico San Carlos

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: RAPIDREHAB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No