Back to resultsMini Lateral Shoulder Approach (MLSA)
Primary Purpose
Shoulder Impingement Syndrome, Rotator Cuff Tendinopathy, Adhesive Capsulitis and Frozen Shoulder Syndrome
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Mini Lateral Shoulder Approach (MLSA)
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Shoulder, Shoulder approach, Lateral Shoulder approach, Shoulder impingement syndrome, Rotator cuff tendinopathy, Adhesive capsulitis, Frozen shoulder syndrome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Dr. Sayed Issa's Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Issa1
Arm Description
Dr.A.Sayed Issa and his team
Outcomes
Primary Outcome Measures
Less surgical procedure time than traditional approaches
25 minutes to 45 minutes, it's depends of rotator cuff tear if exist or not.
Less rehabilitation time than traditional approaches
6 - 8 weeks
Passive physiotherapy immediately
next day of surgery
Active physiotherapy without rotator cuff tear
after two weeks of surgery
Mini cosmetic incision to the shoulder
4 - 5 cm
Active physiotherapy with rotator cuff tear
after three weeks of surgery
Secondary Outcome Measures
very good patients satisfaction
after 8 weeks
Restore deltoid muscle strength
about 3 months after surgery
Full Information
NCT ID
NCT04766905
First Posted
February 12, 2021
Last Updated
February 19, 2021
Sponsor
Issa, Abdulhamid Sayed, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT04766905
Brief Title
Mini Lateral Shoulder Approach
Acronym
MLSA
Official Title
Mini Lateral Shoulder Approach
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
January 17, 2021 (Actual)
Study Completion Date
February 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Issa, Abdulhamid Sayed, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Issa1
Arm Type
Experimental
Arm Description
Dr.A.Sayed Issa and his team
Intervention Type
Procedure
Intervention Name(s)
Mini Lateral Shoulder Approach (MLSA)
Other Intervention Name(s)
Second Sayed Issa's Approach
Intervention 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.
Primary Outcome Measure Information:
Title
Less surgical procedure time than traditional approaches
Description
25 minutes to 45 minutes, it's depends of rotator cuff tear if exist or not.
Time Frame
up to two years
Title
Less rehabilitation time than traditional approaches
Description
6 - 8 weeks
Time Frame
up to two years
Title
Passive physiotherapy immediately
Description
next day of surgery
Time Frame
up to two years
Title
Active physiotherapy without rotator cuff tear
Description
after two weeks of surgery
Time Frame
up to two years
Title
Mini cosmetic incision to the shoulder
Description
4 - 5 cm
Time Frame
up to two years
Title
Active physiotherapy with rotator cuff tear
Description
after three weeks of surgery
Time Frame
up to two years
Secondary Outcome Measure Information:
Title
very good patients satisfaction
Description
after 8 weeks
Time Frame
up to two years
Title
Restore deltoid muscle strength
Description
about 3 months after surgery
Time Frame
up to two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Dr. Sayed Issa's Clinic
City
Aleppo
Country
Syrian Arab Republic
12. IPD Sharing Statement
Learn more about this trial
Mini Lateral Shoulder Approach
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