Mini Lateral Shoulder Approach (MLSA)

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

Study Overview

• Status: Completed
• Conditions: Shoulder Impingement Syndrome; Rotator Cuff Tendinopathy; Adhesive Capsulitis and Frozen Shoulder Syndrome
• Intervention / Treatment: Procedure: Mini Lateral Shoulder Approach (MLSA)

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Aleppo, Syrian Arab Republic
    • Dr. Sayed Issa's Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Issa1; Dr.A.Sayed Issa and his team

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.; Other Names: Second Sayed Issa's Approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Less rehabilitation time than traditional approaches	6 - 8 weeks	up to two years
Passive physiotherapy immediately	next day of surgery	up to two years
Active physiotherapy without rotator cuff tear	after two weeks of surgery	up to two years
Mini cosmetic incision to the shoulder	4 - 5 cm	up to two years
Active physiotherapy with rotator cuff tear	after three weeks of surgery	up to two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
very good patients satisfaction	after 8 weeks	up to two years
Restore deltoid muscle strength	about 3 months after surgery	up to two years

Collaborators and Investigators

• Sponsor: Issa, Abdulhamid Sayed, M.D.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): January 17, 2021
• Study Completion (Actual): February 4, 2021

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Shoulder; Adhesive capsulitis; Shoulder impingement syndrome; Rotator cuff tendinopathy; Shoulder approach; Lateral Shoulder approach; Frozen shoulder syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Shoulder Injuries; Tendon Injuries; Syndrome; Tendinopathy; Shoulder Impingement Syndrome; Bursitis
• Other Study ID Numbers: Second Sayed Issa's Approach

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No