Mini Lateral Shoulder Approach

NCT04766905 | Completed DMC

• 1 other identifier: Second Sayed Issa's Approach
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• very good patients satisfaction

  up to two years

• Restore deltoid muscle strength

  up to two years

Study Arms (1)

Issa1

EXPERIMENTAL

Dr.A.Sayed Issa and his team

Procedure: Mini Lateral Shoulder Approach (MLSA)

Interventions

Mini Lateral Shoulder Approach (MLSA) PROCEDURE

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.

Also known as: Second Sayed Issa's Approach

Issa1

Eligibility Criteria

• Age: 16 Years - 73 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Issa, Abdulhamid Sayed, M.D.: lead

Study Sites (1)

Dr. Sayed Issa's Clinic

Aleppo, Syria

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 23, 2021
• Study Start: January 17, 2019
• Primary Completion: January 17, 2021
• Study Completion: February 4, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

SY (1)