Anterior Shoulder InstabilitySLIDYNCT07644624
Sling vs. Dynamic Shoulder Stabilizer After Soft Tissue Shoulder Instability Surgery (SLIDY)
A study testing Dynamic Immobilizer and Conventional fabric arm sling in people with Anterior Shoulder Instability and Shoulder Instability, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
This randomized controlled trial seeks to address a significant clinical gap by evaluating the outcomes of two postoperative immobilization methods following arthroscopic soft tissue surgery for anterior shoulder instability: a standard static arm sling and a dynamic shoulder orthosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Shoulder Instability, Shoulder Instability, Shoulder Dislocation
- What is being tested?
- Dynamic Immobilizer and Conventional fabric arm sling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2026to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years undergoing arthroscopic soft-tissue stabilization for anterior shoulder instability (Bankart repair ± Hill-Sachs remplissage).
- Ability and willingness to comply with the study protocol and scheduled follow-ups.
- Provision of written informed consent.
Who cannot join
- Significant glenoid bone loss requiring bony augmentation procedures (e.g., bone block procedures, Latarjet).
- Concomitant rotator cuff repair or fracture fixation.
- Contraindication to MRI (e.g., pacemaker, claustrophobia, incompatible implants).
- Cognitive impairment, language barriers, or logistical inability to attend follow-up visits.
- Previous ipsilateral shoulder surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hady Ezzeddine, MD contact
Spain1 site, 1 recruiting
- Recruiting
Bellvitge University Hospital
L'Hospitalet de Llobregat, Catalonia, 08907
Abdul-ilah Hachem, MD, +4609406030, abelhachem@gmail.com
Hady Ezzeddine, MD, hadyezz@gmail.com
About this study
Official title: Sling vs. Dynamic Shoulder Stabilizer After Soft Tissue Shoulder Instability Surgery ("SLIDY"): A Pilot Randomized Controlled Trial Assessing Feasibility, Early Functional Recovery, and Structural Healing
This randomized controlled trial seeks to address a significant clinical gap by evaluating the outcomes of two postoperative immobilization methods following arthroscopic soft tissue surgery for anterior shoulder instability: a standard static arm sling and a dynamic shoulder orthosis.
Read the detailed description
The present study is a pilot trial that aims to compare outcomes between patients immobilized using a standard arm sling and those managed with a dynamic shoulder orthosis (specifically, the medi® Shoulder action brace) following arthroscopic soft tissue stabilization for anterior shoulder instability. This trial will evaluate the impact of these two immobilization methods on early shoulder function, pain, recurrence, and patient satisfaction, while primarily assessing the feasibility of a future definitive trial. This is a prospective, single-center, pilot randomized controlled trial with parallel groups. Participants will be allocated in a 1:1 ratio to either the dynamic orthosis or the standard sling. The trial seeks to determine whether dynamic immobilization designed to facilitate controlled activity offers measurable advantages in early function, comfort, or recurrence risk compared to standard arm slings.
- Being tested
- Dynamic Immobilizer, Conventional fabric arm sling
- Keywords
- Arthroscopic Bankart Repair, Hill-Sachs Remplissage, Dynamic Shoulder Orthosis, Postoperative Immobilization, Shoulder Rehabilitation
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic ImmobilizerDevice
Also called medi® Shoulder action brace
An adjustable strap system applied immediately post-surgery that permits movement of the shoulder joint while simultaneously limiting potentially harmful ranges of motion and translations. It is worn continuously for 3 weeks.
Conventional fabric arm slingDevice
Static immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Immobilizer | Experimental | Continuous wear of the dynamic shoulder orthosis for 3 weeks post-surgery, followed by a standardized physiotherapy protocol. Receives: Device: Dynamic Immobilizer |
| Standard Arm Sling | Active comparator | Continuous wear of a conventional fabric arm sling for 3 weeks post-surgery, followed by a standardized physiotherapy protocol. Receives: Device: Conventional fabric arm sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility composite (Recruitment, Retention, and Adherence)
Evaluation of the feasibility of conducting a definitive randomized controlled trial by measuring the recruitment rate (percentage of eligible enrolled), retention/follow-up completion rates, and protocol adherence (self-reported and therapist-verified). Safety and device-related adverse events will also be recorded.
Measured: Up to 12 months post-surgery.
Secondary outcomes (7)
Western Ontario Shoulder Instability Index (WOSI)
Patient-reported functional outcome assessing quality of life related to shoulder instability.
Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Rowe Score
Clinical assessment of shoulder stability, mobility, and function.
Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Constant-Murley Score
Clinical assessment of general shoulder function, including pain, activities of daily living, range of motion, and strength.
Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Subjective Shoulder Value (SSV)
Patient-reported subjective function of the shoulder expressed as a percentage of a normal shoulder.
Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Range of Motion (ROM)
Active and passive flexion, abduction, and rotation measured via standardized goniometry by two blinded assessors.
Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Patient-reported outcome measure assessing physical function, symptoms, and related quality of life of the upper extremity.
Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
MRI Evaluation of Structural Healing
Assessment of capsulolabral integrity and bone defect remodeling, scored as intact, partial, or re-tear by two blinded physicians.
Measured: Between 6 and 12 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start15 Jun 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Shoulder InstabilityStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul-ilah Hachem, Hospital Universitari de Bellvitge
- Investigators
- Abdul-ilah Hachem, MD, Principal investigator, Head of the Shoulder Unit, Department of Orthopaedics, Bellvitge Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644624
- Sponsor's protocol ID
- ICPS037/25
- Other IDs
- ICPS037/25
- Acronym
- SLIDY
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be anonymized and stored in encrypted institutional servers in accordance with GDPR and HIPAA regulations. No data will be transferred to third parties outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sling vs. Dynamic Shoulder Stabilizer After Soft Tissue Shoulder Instability Surgery ("SLIDY"): A Pilot Randomized Controlled Trial Assessing Feasibility, Early Functional Recovery, and Structural Healing
- ClinicalTrials.gov ID
- NCT07644624
- Acronym / sponsor ID
- SLIDY / ICPS037/25
- Keywords
- Arthroscopic Bankart Repair, Hill-Sachs Remplissage, Dynamic Shoulder Orthosis, Postoperative Immobilization, Shoulder Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 12 Jun 2026 (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.
This randomized controlled trial seeks to address a significant clinical gap by evaluating the outcomes of two postoperative immobilization methods following arthroscopic soft tissue surgery for anterior shoulder instability: a standard static arm sling and a dynamic shoulder orthosis.
Detailed description
The present study is a pilot trial that aims to compare outcomes between patients immobilized using a standard arm sling and those managed with a dynamic shoulder orthosis (specifically, the medi® Shoulder action brace) following arthroscopic soft tissue stabilization for anterior shoulder instability. This trial will evaluate the impact of these two immobilization methods on early shoulder function, pain, recurrence, and patient satisfaction, while primarily assessing the feasibility of a future definitive trial. This is a prospective, single-center, pilot randomized controlled trial with parallel groups. Participants will be allocated in a 1:1 ratio to either the dynamic orthosis or the standard sling. The trial seeks to determine whether dynamic immobilization designed to facilitate controlled activity offers measurable advantages in early function, comfort, or recurrence risk compared to standard arm slings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic Immobilizer | Experimental | Device: Dynamic ImmobilizerContinuous wear of the dynamic shoulder orthosis for 3 weeks post-surgery, followed by a standardized physiotherapy protocol. |
| Standard Arm Sling | Active comparator | Device: Conventional fabric arm slingContinuous wear of a conventional fabric arm sling for 3 weeks post-surgery, followed by a standardized physiotherapy protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥18 years undergoing arthroscopic soft-tissue stabilization for anterior shoulder instability (Bankart repair ± Hill-Sachs remplissage).
- Ability and willingness to comply with the study protocol and scheduled follow-ups.
- Provision of written informed consent.
Key exclusion criteria (5 listed)
- Significant glenoid bone loss requiring bony augmentation procedures (e.g., bone block procedures, Latarjet).
- Concomitant rotator cuff repair or fracture fixation.
- Contraindication to MRI (e.g., pacemaker, claustrophobia, incompatible implants).
- Cognitive impairment, language barriers, or logistical inability to attend follow-up visits.
- Previous ipsilateral shoulder surgery.
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 |
|---|---|---|
| Dynamic ImmobilizerAlso: medi® Shoulder action braceAn adjustable strap system applied immediately post-surgery that permits movement of the shoulder joint while simultaneously limiting potentially harmful ranges of motion and translations. It is worn continuously for 3 weeks. | Device | Dynamic Immobilizer |
| Conventional fabric arm slingStatic immobilization using a conventional fabric arm sling applied immediately post-surgery and worn continuously for 3 weeks. | Device | Standard Arm Sling |
Primary outcome
Feasibility composite (Recruitment, Retention, and Adherence)
Time frame: Up to 12 months post-surgery.
Evaluation of the feasibility of conducting a definitive randomized controlled trial by measuring the recruitment rate (percentage of eligible enrolled), retention/follow-up completion rates, and protocol adherence (self-reported and therapist-verified). Safety and device-related adverse events will also be recorded.
7 secondary outcomes
Western Ontario Shoulder Instability Index (WOSI)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Rowe Score
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Constant-Murley Score
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Subjective Shoulder Value (SSV)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Range of Motion (ROM)
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Score
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months.
MRI Evaluation of Structural Healing
Time frame: Between 6 and 12 months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Data will be anonymized and stored in encrypted institutional servers in accordance with GDPR and HIPAA regulations. No data will be transferred to third parties outside the study team.
Related trials for Anterior Shoulder Instability
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
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Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
Recruiting
Surgical Stabilization of Anterior Shoulder Instability Using the Open Latarjet Procedure, With or Without Anterior Capsuloplasty Using the Coracoacromial Ligament.
Recurrent Anterior Shoulder Instability
Recruiting
Arthroscopic Stabilization of Anterior Shoulder Instability With Subcritical Glenoid Bone Loss
Anterior Shoulder Instability
Active, not recruiting
Anterior Shoulder Instability Treated With a Semitendinosus Subscapular Sling Procedure
Anterior Shoulder Dislocation, Joint Instability
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.
Hady Ezzeddine, MD contact
Abdul-ilah Hachem, MD principal investigator
Head of the Shoulder Unit, Department of Orthopaedics, Bellvitge Univeristy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Immobilizer and Conventional fabric arm sling in people with Anterior Shoulder Instability and Shoulder Instability, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdul-ilah Hachem, MD (+34609406030, abelhachem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility composite (Recruitment, Retention, and Adherence) (time frame: Up to 12 months post-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 17 Jun 2026.