Rotator Cuff Tear RepairRAPIDREHABNCT04458025
Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.
A study testing Standard rehabilitation program and Early rehabilitation program in people with Rotator Cuff Tear Repair, run by Borja Alcobía-Díaz MD, PhD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Tear Repair
- What is being tested?
- Standard rehabilitation program and Early rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.
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.
Read more
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.
Read the 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.
- Conditions
- Rotator Cuff Tear Repair
- Being tested
- Standard rehabilitation program, Early rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard rehabilitation programOther
Standard rehabilitation will start 4 weeks after surgery according to the standard of cre
Early rehabilitation programOther
Early rehabilitation program will start 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard rehabilitation program | Active comparator | Standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation Receives: Other: Standard rehabilitation program |
| Early rehabilitation program | Experimental | Early rehabilitation program will start passive mobilization during second week after surgery, including controlled external rotation movements Receives: Other: Early rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality
Functionality assessment using ASES (American Shoulder and Elbow Surgeons) scale
Measured: 12 months after surgery
Secondary outcomes (8)
Functionality-Constant-Murley scale
Functionality assessment using Constant-Murley scale
Measured: 12 months after surgery
Functionality-UCLA
Functionality assessment using UCLA scale
Measured: 12 months after surgery
Visual Analigic Scale (VAS)
Pain estimation from 0 to 10
Measured: 12 months after surgery
Range of motion
Range of motion measured in degrees of a circle
Measured: 12 months after surgery
Analgesic use
Need of analgesic drugs during the follow up period
Measured: 12 months after surgery
EuroQol Visual Analogue Scale 5 Dimensions
Quality of life
Measured: 12 months after surgery
Complications
Complications related to the surgery or rehabilitation
Measured: 12 months after surgery
MRI rotator cuff retear ratio
MRI rotator cuff retear ratio determinate by MRI
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023
Why it stopped: End of Institution laboral relationship with PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Borja Alcobía-Díaz MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Borja Alcobía-Díaz MD, PhD, Hospital San Carlos, Madrid
- Investigators
- Borja Alcobía Díaz, MD PhD, Principal investigator, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458025
- Sponsor's protocol ID
- RAPIDREHAB
- Acronym
- RAPIDREHAB
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Clinical Trial Comparing Early Versus Delayed Postoperative Mobilization After Arthroscopic Rotator Cuff Tear Reapair.
- ClinicalTrials.gov ID
- NCT04458025
- Acronym / sponsor ID
- RAPIDREHAB / RAPIDREHAB
- Conditions
- Rotator Cuff Tear Repair
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: End of Institution laboral relationship with PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Borja Alcobía-Díaz MD, PhDUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation program | Active comparator | Other: Standard rehabilitation programStandard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation |
| Early rehabilitation program | Experimental | Other: Early rehabilitation programEarly rehabilitation program will start passive mobilization during second week after surgery, including controlled external rotation movements |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard rehabilitation programStandard rehabilitation will start 4 weeks after surgery according to the standard of cre | Other | Standard rehabilitation program |
| Early rehabilitation programEarly rehabilitation program will start 2 weeks | Other | Early rehabilitation program |
Primary outcome
Functionality
Time frame: 12 months after surgery
Functionality assessment using ASES (American Shoulder and Elbow Surgeons) scale
8 secondary outcomes
Functionality-Constant-Murley scale
Time frame: 12 months after surgery
Functionality-UCLA
Time frame: 12 months after surgery
Visual Analigic Scale (VAS)
Time frame: 12 months after surgery
Range of motion
Time frame: 12 months after surgery
Analgesic use
Time frame: 12 months after surgery
EuroQol Visual Analogue Scale 5 Dimensions
Time frame: 12 months after surgery
Complications
Time frame: 12 months after surgery
MRI rotator cuff retear ratio
Time frame: 12 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borja Alcobía Díaz, MD PhD principal investigator
Hospital Clinico San Carlos
Questions about this trial
What is this clinical trial studying?
A study testing Standard rehabilitation program and Early rehabilitation program in people with Rotator Cuff Tear Repair, run by Borja Alcobía-Díaz MD, PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.