Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)

Rotator Cuff Tear Clinical Trial

— HLSSM  

Official title:

Sayed Issa's Hybrid Limited Shoulder Surgical Management (HLSSM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897866
• Other study ID #: Sayed Issa's HLSSM
• Secondary ID: HLSSM
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 12, 2023

Study information

• Verified date: September 2020
• Source: Issa, Abdulhamid Sayed, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) is a limited lateral approach to the shoulder arthroscopically guided. Which achieves less surgical trauma and smaller surgical incision than even in Mini Lateral Shoulder Approach (MLSA).

Description:

After making a full clinical, X-rays and MRI examinations of the shoulder, and finding Shoulder Impingement Syndrome, Adhesive Capsulitis, Rotator Cuff Tear, or Hill-Sachs lesion, we decide to manage the problem surgically We can survey the shoulder from the inside and determine the shape, size and the exact position of the defect by shoulder arthroscopy. The patient is operated on under general anesthesia; shoulder arthroscopy can be performed in the lateral decubitus or beach chair position which is the basic shoulder arthroscopy (Beach Chair Patient Positioning). After identifying the full characteristics of the lesion, we go for Mini Lateral Shoulder Approach (MLSA), as known as Second Sayed Issa's Approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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
• Uncontrolled 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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bankart Lesions
• Bursitis
• Frozen Shoulder
• Hill-Sachs Lesion
• Rotator Cuff Injuries
• Rotator Cuff Tear
• Shoulder Impingement Syndrome
• Syndrome
• Tendinopathy

Intervention

Procedure:
• Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management
Using Arthroscopy and then Limited Opening by Mini Lateral Shoulder Approach (MLSA) for the shoulder surgery.

Locations

Country	Name	City	State
Syrian Arab Republic	Dr. Abdulhamid Sayed Issa 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 open surgery trauma	Directly going to the goal lesion with less expansion	25 minutes to 45 minutes,
Secondary	Smaller surgical incision than MLSA	Directly going to the goal lesion	Less than 5 cm

External Links

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