Mini Lateral Shoulder Approach

Shoulder Impingement Syndrome Clinical Trial

— MLSA  

Official title:

Mini Lateral Shoulder Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766905
• Other study ID #: Second Sayed Issa's Approach
• Status: Completed
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: February 4, 2021

Study information

• Verified date: February 2021
• Source: Issa, Abdulhamid Sayed, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The incision is very useful and easy for the direct lateral shoulder joint exposure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 4, 2021
• Est. primary completion date: January 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 73 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis and Frozen Shoulder Syndrome
• Bursitis
• Rotator Cuff Tendinopathy
• Shoulder Impingement Syndrome
• Syndrome
• Tendinopathy

Intervention

Procedure:
• Mini Lateral Shoulder Approach (MLSA)
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.

Locations

Country	Name	City	State
Syrian Arab Republic	Dr. Sayed Issa's Clinic	Aleppo

Sponsors (1)

Lead Sponsor	Collaborator
Issa, Abdulhamid Sayed, M.D.

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Less surgical procedure time than traditional approaches	25 minutes to 45 minutes, it's depends of rotator cuff tear if exist or not.	up to two years
Primary	Less rehabilitation time than traditional approaches	6 - 8 weeks	up to two years
Primary	Passive physiotherapy immediately	next day of surgery	up to two years
Primary	Active physiotherapy without rotator cuff tear	after two weeks of surgery	up to two years
Primary	Mini cosmetic incision to the shoulder	4 - 5 cm	up to two years
Primary	Active physiotherapy with rotator cuff tear	after three weeks of surgery	up to two years
Secondary	very good patients satisfaction	after 8 weeks	up to two years
Secondary	Restore deltoid muscle strength	about 3 months after surgery	up to two years