NCT05897866

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 26, 2023

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

May 12, 2023

Last Update Submit

June 23, 2023

Conditions

Keywords

ShoulderShoulder approachLateral Shoulder approachShoulder impingement syndromeRotator cuff tendinopathyAdhesive capsulitisFrozen shoulder syndromeMLSAShoulder arthroscopyMini Lateral Shoulder ApproachSecond Sayed Issa's ApproachHill-sachs lesionmini-incision releaseTendinopathyarthroscopytendon injuries

Outcome Measures

Primary Outcomes (1)

  • Less open surgery trauma

    Directly going to the goal lesion with less expansion

    25 minutes to 45 minutes,

Secondary Outcomes (1)

  • Smaller surgical incision than MLSA

    Less than 5 cm

Study Arms (1)

Issa3

EXPERIMENTAL

Dr.A.Sayed Issa and his team

Procedure: Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management

Interventions

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

Also known as: Sayed Issa's HSSM
Issa3

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdulhamid Sayed Issa Clinic

Aleppo, Syria

Location

Related Links

MeSH Terms

Conditions

Shoulder Impingement SyndromeBursitisRotator Cuff InjuriesBankart LesionsTendinopathyTendon Injuries

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesRuptureShoulder FracturesFractures, BoneMuscular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2023

First Posted

June 9, 2023

Study Start

September 1, 2020

Primary Completion

May 12, 2023

Study Completion

May 12, 2023

Last Updated

June 26, 2023

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share
More information

Locations