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Trial record 1 of 1 for:    HLSSM
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Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) (HLSSM)

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ClinicalTrials.gov Identifier: NCT05897866
Recruitment Status : Completed
First Posted : June 9, 2023
Last Update Posted : June 26, 2023
Sponsor:
Information provided by (Responsible Party):
Issa, Abdulhamid Sayed, M.D.

Brief 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).

Condition or disease Intervention/treatment Phase
Shoulder Impingement Syndrome Adhesive Capsulitis Rotator Cuff Tear Hill-Sachs Lesion Frozen Shoulder Tendinopathy Procedure: Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sayed Issa's Hybrid Limited Shoulder Surgical Management (HLSSM)
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : May 12, 2023
Actual Study Completion Date : May 12, 2023

Arm Intervention/treatment
Experimental: Issa3
Dr.A.Sayed Issa and his team
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.
Other Name: Sayed Issa's HSSM




Primary Outcome Measures :
  1. Less open surgery trauma [ Time Frame: 25 minutes to 45 minutes, ]
    Directly going to the goal lesion with less expansion


Secondary Outcome Measures :
  1. Smaller surgical incision than MLSA [ Time Frame: Less than 5 cm ]
    Directly going to the goal lesion



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05897866


Locations
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Syrian Arab Republic
Dr. Abdulhamid Sayed Issa Clinic
Aleppo, Syrian Arab Republic
Sponsors and Collaborators
Issa, Abdulhamid Sayed, M.D.
Additional Information:
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Responsible Party: Issa, Abdulhamid Sayed, M.D.
ClinicalTrials.gov Identifier: NCT05897866    
Other Study ID Numbers: Sayed Issa's HLSSM
HLSSM ( Other Identifier: Dr. Abdulhamid Sayed Issa Clinic )
First Posted: June 9, 2023    Key Record Dates
Last Update Posted: June 26, 2023
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: http://www.asayedissa.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Issa, Abdulhamid Sayed, M.D.:
Shoulder
Shoulder approach
Lateral Shoulder approach
Shoulder impingement syndrome
Rotator cuff tendinopathy
Adhesive capsulitis
Frozen shoulder syndrome
MLSA
Shoulder arthroscopy
Mini Lateral Shoulder Approach
Second Sayed Issa's Approach
Hill-sachs lesion
mini-incision release
Tendinopathy
arthroscopy
tendon injuries
Additional relevant MeSH terms:
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Tendinopathy
Bursitis
Shoulder Impingement Syndrome
Syndrome
Rotator Cuff Injuries
Bankart Lesions
Disease
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases
Joint Diseases
Shoulder Fractures
Fractures, Bone