Clinical trial NCT04458025: Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.
Official title: Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tear Repair
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Functionality
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Functionality-Constant-Murley scale
timeFrame: 12 months after surgery
measure: Functionality-UCLA
timeFrame: 12 months after surgery
measure: Pain
timeFrame: 12 months after surgery
measure: Range of motion
timeFrame: 12 months after surgery
measure: Analgesic use
timeFrame: 12 months after surgery
measure: Quality of life
timeFrame: 12 months after surgery
measure: Complications
timeFrame: 12 months after surgery
measure: MRI rotator cuff retear ratio
timeFrame: 12 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clinico San Carlos
name: Borja Alcobía Díaz, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: