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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotator Cuff Tear Repair

Intervention / Treatment
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* Other: Standard rehabilitation program
* Other: Early rehabilitation program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |