Shoulder Impingement SyndromeMLSANCT04766905
Mini Lateral Shoulder Approach
A study testing Mini Lateral Shoulder Approach (MLSA) in people with Shoulder Impingement Syndrome and Rotator Cuff Tendinopathy, run by Issa, Abdulhamid Sayed, M.D. at 1 site in Syria.
Trial summary
The incision is very useful and easy for the direct lateral shoulder joint exposure. Read more about this study
- Who is it for?
- Ages 16 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Impingement Syndrome, Rotator Cuff Tendinopathy, Adhesive Capsulitis and Frozen Shoulder Syndrome
- What is being tested?
- Mini Lateral Shoulder Approach (MLSA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSyria
- Study dates
- 17 Jan 2019to 4 Feb 2021
- 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 16 to 73 years
- All sexes
- Healthy volunteers accepted
- 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
- Un controlled 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
- Patients with history of Carpal Tunnel release surgery failure
Trial locations and contacts
1 site in 1 country.
About this study
The incision is very useful and easy for the direct lateral shoulder joint exposure.
Read the detailed description
The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally.
After clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly.
Throw this approach can be made acromioplasty and rotator cuff tears repair especially upper part of rotator cuff tear very easily.
For wound closure the acromionic deltoid origin is reattached to the acromial edge by long period synthetic absorbable sutures as PDS and PDO, or non absorbable sutures as Polyester suture, under skin and skin sutures are made.
- Conditions
- Shoulder Impingement Syndrome, Rotator Cuff Tendinopathy, Adhesive Capsulitis and Frozen Shoulder Syndrome
- Being tested
- Mini Lateral Shoulder Approach (MLSA)
- Keywords
- Shoulder, Shoulder approach, Lateral Shoulder approach, Shoulder impingement syndrome, Rotator cuff tendinopathy, Adhesive capsulitis, Frozen shoulder syndrome
- Medical subject headings
- Shoulder Impingement Syndrome, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini Lateral Shoulder Approach (MLSA)Procedure or surgery
Also called Second Sayed Issa's Approach
The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally.
After clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly.
| Study group | Role | What they receive |
|---|---|---|
| Issa1 | Experimental | Dr.A.Sayed Issa and his team Receives: Procedure: Mini Lateral Shoulder Approach (MLSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Less surgical procedure time than traditional approaches
25 minutes to 45 minutes, it's depends of rotator cuff tear if exist or not.
Measured: up to two years
Less rehabilitation time than traditional approaches
6 - 8 weeks
Measured: up to two years
Passive physiotherapy immediately
next day of surgery
Measured: up to two years
Active physiotherapy without rotator cuff tear
after two weeks of surgery
Measured: up to two years
Mini cosmetic incision to the shoulder
4 - 5 cm
Measured: up to two years
Active physiotherapy with rotator cuff tear
after three weeks of surgery
Measured: up to two years
Secondary outcomes (2)
very good patients satisfaction
after 8 weeks
Measured: up to two years
Restore deltoid muscle strength
about 3 months after surgery
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start17 Jan 2019
- Primary completion17 Jan 2021
- Study completion4 Feb 2021
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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Issa, Abdulhamid Sayed, M.D.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766905
- Sponsor's protocol ID
- Second Sayed Issa's Approach
- Acronym
- MLSA
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini Lateral Shoulder Approach
- ClinicalTrials.gov ID
- NCT04766905
- Acronym / sponsor ID
- MLSA / Second Sayed Issa's Approach
- Conditions
- Shoulder Impingement Syndrome, Rotator Cuff Tendinopathy, Adhesive Capsulitis and Frozen Shoulder Syndrome
- Keywords
- Shoulder, Shoulder approach, Lateral Shoulder approach, Shoulder impingement syndrome, Rotator cuff tendinopathy, Adhesive capsulitis, Frozen shoulder syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Issa, Abdulhamid Sayed, M.D.
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 23 Feb 2021 (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 incision is very useful and easy for the direct lateral shoulder joint exposure.
Detailed description
The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally.
After clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly.
Throw this approach can be made acromioplasty and rotator cuff tears repair especially upper part of rotator cuff tear very easily.
For wound closure the acromionic deltoid origin is reattached to the acromial edge by long period synthetic absorbable sutures as PDS and PDO, or non absorbable sutures as Polyester suture, under skin and skin sutures are made.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Issa1 | Experimental | Procedure: Mini Lateral Shoulder Approach (MLSA)Dr.A.Sayed Issa and his team |
Who may qualify
- Ages
- 16 to 73 years
- Sex
- All
- Healthy volunteers
- 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 (7 listed)
- Patients with femur head immigration on X-ray
- Patients with injury for more than six months
- Un controlled 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 |
|---|---|---|
| Mini Lateral Shoulder Approach (MLSA)Also: Second Sayed Issa's ApproachThe skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally. After clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly. | Procedure or surgery | Issa1 |
Primary outcome
Less surgical procedure time than traditional approaches
Time frame: up to two years
25 minutes to 45 minutes, it's depends of rotator cuff tear if exist or not.
Less rehabilitation time than traditional approaches
Time frame: up to two years
6 - 8 weeks
Passive physiotherapy immediately
Time frame: up to two years
next day of surgery
Active physiotherapy without rotator cuff tear
Time frame: up to two years
after two weeks of surgery
Mini cosmetic incision to the shoulder
Time frame: up to two years
4 - 5 cm
Active physiotherapy with rotator cuff tear
Time frame: up to two years
after three weeks of surgery
2 secondary outcomes
very good patients satisfaction
Time frame: up to two years
Restore deltoid muscle strength
Time frame: up to two years
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 23 Feb 2021.
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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 Mini Lateral Shoulder Approach (MLSA) in people with Shoulder Impingement Syndrome and Rotator Cuff Tendinopathy, 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 7 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 23 Feb 2021. 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 surgical procedure time than traditional approaches (time frame: up to two years). The study lists 6 primary outcomes in all. 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 23 Feb 2021.