Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tear Repair
- Sponsor
- Borja Alcobía-Díaz MD, PhD
- Enrollment
- 64
- Primary Endpoint
- Functionality
- Last Updated
- 5 years ago
Overview
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.
Investigators
Borja Alcobía-Díaz MD, PhD
MD, PhD
Hospital San Carlos, Madrid
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.
Outcomes
Primary Outcomes
Functionality
Time Frame: 12 months after surgery
Functionality assessment using ASES scale
Secondary Outcomes
- Functionality-Constant-Murley scale(12 months after surgery)
- Pain(12 months after surgery)
- Functionality-UCLA(12 months after surgery)
- Analgesic use(12 months after surgery)
- Complications(12 months after surgery)
- MRI rotator cuff retear ratio(12 months after surgery)
- Range of motion(12 months after surgery)
- Quality of life(12 months after surgery)