Mini Lateral Shoulder Approach

Not Applicable

Completed

• Conditions: Rotator Cuff Tendinopathy; Adhesive Capsulitis and Frozen Shoulder Syndrome; Shoulder Impingement Syndrome
• Interventions: Procedure: Mini Lateral Shoulder Approach (MLSA)

• Registration Number: NCT04766905
• Lead Sponsor: Issa, Abdulhamid Sayed, M.D.

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.

Study Timeline

• Study Start: 2019-01-17
• Primary Completion: 2021-01-17
• Status Verified: 2021-02
• Study Completion: 2021-02-04
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-19
• Last Update Submitted: 2021-02-19
• Study First Posted: 2021-02-23
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Issa1	Mini Lateral Shoulder Approach (MLSA)	Dr.A.Sayed Issa and his team

Primary Outcome Measures

Name	Time	Method
Active physiotherapy without rotator cuff tear	up to two years	after two weeks of surgery
Less rehabilitation time than traditional approaches	up to two years	6 - 8 weeks
Mini cosmetic incision to the shoulder	up to two years	4 - 5 cm
Passive physiotherapy immediately	up to two years	next day of surgery
Less surgical procedure time than traditional approaches	up to two years	25 minutes to 45 minutes, it's depends of rotator cuff tear if exist or not.
Active physiotherapy with rotator cuff tear	up to two years	after three weeks of surgery

Secondary Outcome Measures

Name	Time	Method
very good patients satisfaction	up to two years	after 8 weeks
Restore deltoid muscle strength	up to two years	about 3 months after surgery

Trial Locations

Locations (1)

Dr. Sayed Issa's Clinic; 🇸🇾 Aleppo, Syrian Arab Republic