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

Primary Purpose

Rotator Cuff Tear Repair

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard rehabilitation program
Early rehabilitation program
Sponsored by
Borja Alcobía-Díaz MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear Repair

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard rehabilitation program

    Early rehabilitation program

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Functionality
    Functionality assessment using ASES scale

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 1, 2020
    Last Updated
    July 1, 2020
    Sponsor
    Borja Alcobía-Díaz MD, PhD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04458025
    Brief Title
    Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.
    Acronym
    RAPIDREHAB
    Official Title
    Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    September 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Borja Alcobía-Díaz MD, PhD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tear Repair

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard rehabilitation program
    Arm Type
    Active Comparator
    Arm Description
    Standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation
    Arm Title
    Early rehabilitation program
    Arm Type
    Experimental
    Arm Description
    Early rehabilitation program will start passive mobilization during second week after surgery, including controlled external rotation movements
    Intervention Type
    Other
    Intervention Name(s)
    Standard rehabilitation program
    Intervention Description
    Standard rehabilitation will start 4 weeks after surgery according to the standard of cre
    Intervention Type
    Other
    Intervention Name(s)
    Early rehabilitation program
    Intervention Description
    Early rehabilitation program will start 2 weeks
    Primary Outcome Measure Information:
    Title
    Functionality
    Description
    Functionality assessment using ASES scale
    Time Frame
    12 months after surgery
    Secondary Outcome Measure Information:
    Title
    Functionality-Constant-Murley scale
    Description
    Functionality assessment using Constant-Murley scale
    Time Frame
    12 months after surgery
    Title
    Functionality-UCLA
    Description
    Functionality assessment using UCLA scale
    Time Frame
    12 months after surgery
    Title
    Pain
    Description
    Pain estimation according to visual analogic scale
    Time Frame
    12 months after surgery
    Title
    Range of motion
    Description
    Range of motion measured in degrees of a circle
    Time Frame
    12 months after surgery
    Title
    Analgesic use
    Description
    Need of analgesic drugs during the follow up period
    Time Frame
    12 months after surgery
    Title
    Quality of life
    Description
    Quality of life according to EQ-5D scale
    Time Frame
    12 months after surgery
    Title
    Complications
    Description
    Complications related to the surgery or rehabilitation
    Time Frame
    12 months after surgery
    Title
    MRI rotator cuff retear ratio
    Description
    MRI rotator cuff retear ratio determinate by MRI
    Time Frame
    12 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Borja Alcobía Díaz, MD PhD
    Phone
    913303638
    Email
    balcobiadiaz@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Borja Alcobía Díaz, MD PhD
    Organizational Affiliation
    Hospital Clinico San Carlos
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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