Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.
- Conditions
- Rotator Cuff Tear Repair
- Interventions
- Other: Standard rehabilitation programOther: Early rehabilitation program
- Registration Number
- NCT04458025
- Lead Sponsor
- Borja Alcobía-Díaz MD, PhD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard rehabilitation program Standard rehabilitation program Standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation Early rehabilitation program Early rehabilitation program Early rehabilitation program will start passive mobilization during second week after surgery, including controlled external rotation movements
- Primary Outcome Measures
Name Time Method Functionality 12 months after surgery Functionality assessment using ASES scale
- Secondary Outcome Measures
Name Time Method Functionality-Constant-Murley scale 12 months after surgery Functionality assessment using Constant-Murley scale
Pain 12 months after surgery Pain estimation according to visual analogic scale
Functionality-UCLA 12 months after surgery Functionality assessment using UCLA scale
Analgesic use 12 months after surgery Need of analgesic drugs during the follow up period
Complications 12 months after surgery Complications related to the surgery or rehabilitation
MRI rotator cuff retear ratio 12 months after surgery MRI rotator cuff retear ratio determinate by MRI
Range of motion 12 months after surgery Range of motion measured in degrees of a circle
Quality of life 12 months after surgery Quality of life according to EQ-5D scale