Supraspinatus InjuryNCT03445494
Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture.
A study testing Brace and Normal sling in people with Supraspinatus Injury, run by Christian Candrian at 1 site in Switzerland.
Trial summary
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling). Both groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Supraspinatus Injury
- What is being tested?
- Brace and Normal sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Jan 2018to 11 Jul 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 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between 18 and 65 years old;
- Presence of an isolated lesion of supraspinatus that can be documented with the MRI and which can be treated surgically by arthroscopy;
- Presence of a supraspinatus lesion according to the Patte criteria with stage 1, 2 or 3 frontal plane ;
- Presence of adipose degeneration ≤ 2 according to Goutallier;
- Written informed consent to participate in the study
Who cannot join
- Presence of a lesion of other rotator cuff tendons;
- Previous surgical procedures of the shoulder;
- Presence of a massive lesion, therefore irreparable, of the cuff detected intra-operatively and not observed during preoperative MRI;
- Presence of relapsing shoulder dislocations;
- Presence of lesions of the glenoidine cercine that require intervention;
- Difficulties to follow the rehabilitation programs;
- Presence of neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases and immunosuppressed patients;
- State of pregnancy (presumed or established) or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture: a Randomized Monocentric Study
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements.
Read the detailed description
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will then perform only passive movements according to pain for the first 6 weeks supported by the physiotherapy, according to standard therapy. The following six weeks passive movements will be associated with active movements . No brace nor normal sling will be used anymore.
Patients are in study for 6 months. During this period quality of life and pain questionnaires are submitted to the patients and a MRI will be done at the end of the study.
- Conditions
- Supraspinatus Injury
- Being tested
- Brace, Normal sling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BraceProcedure or surgery
A brace to be weared according to protocol
Normal slingProcedure or surgery
A normal sling to be weared according to protocol
| Study group | Role | What they receive |
|---|---|---|
| Brace | Experimental | After surgery the patient must wear the brace for 6 weeks, for the first 3 weeks during day and night and for the following 3 weeks only at night Receives: Procedure: Brace |
| Normal sling | Experimental | After surgery the patient must wear the normal sling for two weeks Receives: Procedure: Normal sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in the rehabilitative therapy
The primary objective of the study is to evaluate two different rehabilitative therapies. Efficacy is measured with a pre and post MRI
Measured: 6 months
Secondary outcomes (2)
Quality of life assessment
Evaluation of the quality of live in both groups through Constant Quality of Life questionnair up to 6 months
Measured: 6 months
re-rupture rate of the supraspinatus tendon
Evaluation of the re-rupture of the supraspinatus tendon though a follow up MRI at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start10 Jan 2018
- Primary completion11 Jul 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraspinatus InjuryStudies 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
- Model description
- randomized 1:1
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Candrian
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Christian Candrian, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Christian Candrian, MD, Study director, EOC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445494
- Sponsor's protocol ID
- ORL-ORT-002
- Status last verified
- Sep 2023
- First submitted
- 22 Jan 2018
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schonweger F, Marbach F, Feltri P, Milev SR, Filardo G, Candrian C. Sling Is Not Inferior to Brace Immobilization After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2025 Jul;41(7):2283-2293. doi: 10.1016/j.arthro.2024.12.023. Epub 2024 Dec 26.
PubMed 39732211
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Abduction Brace Against Normal Sling After Arthroscopical Rotator Cuff Suture: a Randomized Monocentric Study
- ClinicalTrials.gov ID
- NCT03445494
- Acronym / sponsor ID
- ORL-ORT-002
- Conditions
- Supraspinatus Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Christian CandrianUniversity, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 26 Feb 2018 (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.
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will be also treated according to standard of care with physiotherapy and progressive introduction of movements.
Detailed description
The patient undergoes arthroscopic surgery to treat rotator cuff injury. At the end of the surgery, the patient will be randomized into group A (brace) or group B (normal sling).
Both groups will then perform only passive movements according to pain for the first 6 weeks supported by the physiotherapy, according to standard therapy. The following six weeks passive movements will be associated with active movements . No brace nor normal sling will be used anymore.
Patients are in study for 6 months. During this period quality of life and pain questionnaires are submitted to the patients and a MRI will be done at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Brace | Experimental | Procedure: BraceAfter surgery the patient must wear the brace for 6 weeks, for the first 3 weeks during day and night and for the following 3 weeks only at night |
| Normal sling | Experimental | Procedure: Normal slingAfter surgery the patient must wear the normal sling for two weeks |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females between 18 and 65 years old;
- Presence of an isolated lesion of supraspinatus that can be documented with the MRI and which can be treated surgically by arthroscopy;
- Presence of a supraspinatus lesion according to the Patte criteria with stage 1, 2 or 3 frontal plane ;
- Presence of adipose degeneration ≤ 2 according to Goutallier;
- Written informed consent to participate in the study
Key exclusion criteria (8 listed)
- Presence of a lesion of other rotator cuff tendons;
- Previous surgical procedures of the shoulder;
- Presence of a massive lesion, therefore irreparable, of the cuff detected intra-operatively and not observed during preoperative MRI;
- Presence of relapsing shoulder dislocations;
- Presence of lesions of the glenoidine cercine that require intervention;
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 |
|---|---|---|
| BraceA brace to be weared according to protocol | Procedure or surgery | Brace |
| Normal slingA normal sling to be weared according to protocol | Procedure or surgery | Normal sling |
Primary outcome
Efficacy in the rehabilitative therapy
Time frame: 6 months
The primary objective of the study is to evaluate two different rehabilitative therapies. Efficacy is measured with a pre and post MRI
2 secondary outcomes
Quality of life assessment
Time frame: 6 months
re-rupture rate of the supraspinatus tendon
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 39732211Schonweger F, Marbach F, Feltri P, Milev SR, Filardo G, Candrian C. Sling Is Not Inferior to Brace Immobilization After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Arthroscopy. 2025 Jul;41(7):2283-2293. doi: 10.1016/j.arthro.2024.12.023. Epub 2024 Dec 26.
- 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.
Christian Candrian, MD study director
EOC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brace and Normal sling in people with Supraspinatus Injury, run by Christian Candrian at 1 site in Switzerland.
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 8 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: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy in the rehabilitative therapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445494, which also lists 1 linked publication.
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 7 Sep 2023.