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

June 23, 2023 updated by: Issa, Abdulhamid Sayed, M.D.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • Sayed Issa's HSSM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Less open surgery trauma
Time Frame: 25 minutes to 45 minutes,
Directly going to the goal lesion with less expansion
25 minutes to 45 minutes,

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smaller surgical incision than MLSA
Time Frame: Less than 5 cm
Directly going to the goal lesion
Less than 5 cm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Issa, Abdulhamid Sayed, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

May 12, 2023

Study Completion (Actual)

May 12, 2023

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sayed Issa's HLSSM
  • HLSSM (Other Identifier: Dr. Abdulhamid Sayed Issa Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rotator Cuff Tear

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe