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

Rotator Cuff Tear Repair Clinical Trial

— RAPIDREHAB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04458025
• Other study ID #: RAPIDREHAB
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2020
• Source: Hospital San Carlos, Madrid
• Contact: Borja Alcobía Díaz, MD PhD
• Phone: 913303638
• Email: balcobiadiaz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear Repair

Intervention

Other:
• Standard rehabilitation program
Standard rehabilitation will start 4 weeks after surgery according to the standard of cre
• Early rehabilitation program
Early rehabilitation program will start 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Borja Alcobía-Díaz MD, PhD

Outcome

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