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
About this trial
This is an interventional treatment trial for Rotator Cuff Tear Repair
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.
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
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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