Clinical trial NCT05897866: Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)
Official title: Sayed Issa's Hybrid Limited Shoulder Surgical Management (HLSSM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Adhesive Capsulitis
Rotator Cuff Tear
Hill-Sachs Lesion
Frozen Shoulder
Tendinopathy
Keywords: 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
Lead sponsor: Issa, Abdulhamid Sayed, M.D.
Sponsor class: INDIV
First posted: 2023-06-09
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Less open surgery trauma
timeFrame: 25 minutes to 45 minutes,
Secondary outcomes:
measure: Smaller surgical incision than MLSA
timeFrame: Less than 5 cm
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Dr. Abdulhamid Sayed Issa Clinic
Study officials:
References: