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

NCT04458025 | Unknown

• 1 other identifier: RAPIDREHAB
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Functionality

  Functionality assessment using ASES scale

  12 months after surgery

Secondary Outcomes (8)

• Functionality-Constant-Murley scale

  12 months after surgery

• Functionality-UCLA

  12 months after surgery

• Pain

  12 months after surgery

• Range of motion

  12 months after surgery

• Analgesic use

  12 months after surgery

Study Arms (2)

Standard rehabilitation program

ACTIVE COMPARATOR

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

Other: Standard rehabilitation program

Early rehabilitation program

EXPERIMENTAL

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

Other: Early rehabilitation program

Interventions

Standard rehabilitation program OTHER

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

Standard rehabilitation program

Early rehabilitation program OTHER

Early rehabilitation program will start 2 weeks

Early rehabilitation program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Borja Alcobía-Díaz MD, PhD: lead

Study Officials

• Borja Alcobía Díaz, MD PhD

  Hospital Clinico San Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Borja Alcobía Díaz, MD PhD

CONTACT

913303638; balcobiadiaz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: September 1, 2020
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: July 7, 2020

Record last verified: 2020-07