Shoulder Impingement SyndromeHLSSMNCT05897866
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)
A study testing Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management in people with Shoulder Impingement Syndrome and Adhesive Capsulitis, run by Issa, Abdulhamid Sayed, M.D. at 1 site in Syria.
Trial summary
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) is a limited lateral approach to the shoulder arthroscopically guided. Which achieves less surgical trauma and smaller surgical incision than even in Mini Lateral Shoulder Approach (MLSA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear
- What is being tested?
- Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSyria
- Study dates
- 1 Sep 2020to 12 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presented with Shoulder Impingement Syndrome refractory to conservative treatment and local steroid injection
- Patients presented with Adhesive Capsulitis and Frozen Shoulder Syndrome refractory to conservative treatment and local steroid injection
- Patients without femur head immigration on X-ray
- Patients with injury for one month to six months maximum
Who cannot join
- Patients with femur head immigration on X-ray
- Patients with injury for more than six months
- Uncontrolled diabetes mellitus type 1 and 2
- Patients with non controlled Vascular hypertension
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sayed Issa's Hybrid Limited Shoulder Surgical Management (HLSSM)
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) is a limited lateral approach to the shoulder arthroscopically guided. Which achieves less surgical trauma and smaller surgical incision than even in Mini Lateral Shoulder Approach (MLSA).
Read the detailed description
After making a full clinical, X-rays and MRI examinations of the shoulder, and finding Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear, or Hill-Sachs lesion, we decide to manage the problem surgically We can survey the shoulder from the inside and determine the shape, size and the exact position of the defect by shoulder arthroscopy.
The patient is operated on under general anesthesia; shoulder arthroscopy can be performed in the lateral decubitus or beach chair position which is the basic shoulder arthroscopy (Beach Chair Patient Positioning).
After identifying the full characteristics of the lesion, we go for Mini Lateral Shoulder Approach (MLSA), as known as Second Sayed Issa's Approach.
- Conditions
- Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear, Hill-Sachs Lesion, Frozen Shoulder, Tendinopathy
- Being tested
- Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management
- Keywords
- Shoulder, Shoulder approach, Lateral Shoulder approach, Shoulder impingement syndrome, Rotator cuff tendinopathy, Adhesive capsulitis, Frozen shoulder syndrome, MLSA, Shoulder arthroscopy, Mini Lateral Shoulder Approach, Second Sayed Issa's Approach, Hill-sachs lesion, mini-incision release, Tendinopathy, arthroscopy, tendon injuries
- Medical subject headings
- Shoulder Impingement Syndrome, Bursitis, Rotator Cuff Injuries, Bankart Lesions, Tendinopathy, Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical ManagementProcedure or surgery
Also called Sayed Issa's HSSM
Using Arthroscopy and then Limited Opening by Mini Lateral Shoulder Approach (MLSA) for the shoulder surgery.
| Study group | Role | What they receive |
|---|---|---|
| Issa3 | Experimental | Dr.A.Sayed Issa and his team Receives: Procedure: Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Less open surgery trauma
Directly going to the goal lesion with less expansion
Measured: 25 minutes to 45 minutes,
Secondary outcomes (1)
Smaller surgical incision than MLSA
Directly going to the goal lesion
Measured: Less than 5 cm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Sep 2020
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Issa, Abdulhamid Sayed, M.D.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897866
- Sponsor's protocol ID
- Sayed Issa's HLSSM
- Other IDs
- HLSSM
- Acronym
- HLSSM
- Status last verified
- Sep 2020
- First submitted
- 12 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sayed Issa's Hybrid Limited Shoulder Surgical Management (HLSSM)
- ClinicalTrials.gov ID
- NCT05897866
- Acronym / sponsor ID
- HLSSM / Sayed Issa's HLSSM
- Conditions
- Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear, Hill-Sachs Lesion, Frozen Shoulder, Tendinopathy
- Keywords
- Shoulder, Shoulder approach, Lateral Shoulder approach, Shoulder impingement syndrome, Rotator cuff tendinopathy, Adhesive capsulitis, Frozen shoulder syndrome, MLSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Issa, Abdulhamid Sayed, M.D.
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 9 Jun 2023 (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.
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) is a limited lateral approach to the shoulder arthroscopically guided. Which achieves less surgical trauma and smaller surgical incision than even in Mini Lateral Shoulder Approach (MLSA).
Detailed description
After making a full clinical, X-rays and MRI examinations of the shoulder, and finding Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear, or Hill-Sachs lesion, we decide to manage the problem surgically We can survey the shoulder from the inside and determine the shape, size and the exact position of the defect by shoulder arthroscopy.
The patient is operated on under general anesthesia; shoulder arthroscopy can be performed in the lateral decubitus or beach chair position which is the basic shoulder arthroscopy (Beach Chair Patient Positioning).
After identifying the full characteristics of the lesion, we go for Mini Lateral Shoulder Approach (MLSA), as known as Second Sayed Issa's Approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Issa3 | Experimental | Procedure: Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical ManagementDr.A.Sayed Issa and his team |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presented with Shoulder Impingement Syndrome refractory to conservative treatment and local steroid injection
- Patients presented with Adhesive Capsulitis and Frozen Shoulder Syndrome refractory to conservative treatment and local steroid injection
- Patients without femur head immigration on X-ray
- Patients with injury for one month to six months maximum
Key exclusion criteria (6 listed)
- Patients with femur head immigration on X-ray
- Patients with injury for more than six months
- Uncontrolled diabetes mellitus type 1 and 2
- Patients with non controlled Vascular hypertension
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
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 |
|---|---|---|
| Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical ManagementAlso: Sayed Issa's HSSMUsing Arthroscopy and then Limited Opening by Mini Lateral Shoulder Approach (MLSA) for the shoulder surgery. | Procedure or surgery | Issa3 |
Primary outcome
Less open surgery trauma
Time frame: 25 minutes to 45 minutes,
Directly going to the goal lesion with less expansion
1 secondary outcome
Smaller surgical incision than MLSA
Time frame: Less than 5 cm
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 26 Jun 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management in people with Shoulder Impingement Syndrome and Adhesive Capsulitis, run by Issa, Abdulhamid Sayed, M.D. at 1 site in Syria.
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 4 inclusion and 6 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 26 Jun 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 Syria. 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?
Less open surgery trauma (time frame: 25 minutes to 45 minutes,). 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 26 Jun 2023.