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Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04458025
Acronym
RAPIDREHAB
Enrollment
0
Registered
2020-07-07
Start date
2020-09-01
Completion date
2023-12-31
Last updated
2026-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear Repair

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, investigators will continue applying the standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation. On the other treatment branch, investigators will start passive mobilization during second week after surgery, including controlled external rotation movements. All recruited patients will be followed-up during 12 months. 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, investigators 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

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, investigators will continue applying the standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation. On the other treatment branch, investigators will start passive mobilization during second week after surgery, including controlled external rotation movements. All recruited patients will be followed-up during 12 months. 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, investigators 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.

Interventions

Standard rehabilitation will start 4 weeks after surgery according to the standard of cre

Early rehabilitation program will start 2 weeks

Sponsors

Borja Alcobía-Díaz MD, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functionality12 months after surgeryFunctionality assessment using ASES (American Shoulder and Elbow Surgeons) scale

Secondary

MeasureTime frameDescription
Functionality-Constant-Murley scale12 months after surgeryFunctionality assessment using Constant-Murley scale
Functionality-UCLA12 months after surgeryFunctionality assessment using UCLA scale
Visual Analigic Scale (VAS)12 months after surgeryPain estimation from 0 to 10
Range of motion12 months after surgeryRange of motion measured in degrees of a circle
Analgesic use12 months after surgeryNeed of analgesic drugs during the follow up period
EuroQol Visual Analogue Scale 5 Dimensions12 months after surgeryQuality of life
Complications12 months after surgeryComplications related to the surgery or rehabilitation
MRI rotator cuff retear ratio12 months after surgeryMRI rotator cuff retear ratio determinate by MRI

Contacts

PRINCIPAL_INVESTIGATORBorja Alcobía Díaz, MD PhD

Hospital Clinico San Carlos

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 17, 2026