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Completed

NCT Number: NCT05897866

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management

Procedure

Using Arthroscopy and then Limited Opening by Mini Lateral Shoulder Approach (MLSA) for the shoulder surgery.

Other names: Sayed Issa's HSSM

Primary outcomes

  1. Less open surgery trauma

    Time frame: 25 minutes to 45 minutes,

    Directly going to the goal lesion with less expansion

Secondary outcomes

  1. Smaller surgical incision than MLSA

    Time frame: Less than 5 cm

    Directly going to the goal lesion

Sponsors and collaborators

Lead sponsor

Issa, Abdulhamid Sayed, M.D.

Indiv

Registry information

Official study title

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

Acronym: HLSSM

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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