Sclerotherapy and Bone Marrow Injection In Aneurysmal Bone Cyst

October 9, 2023 updated by: Abdallah Mousa Elwany Hassan, Al-Azhar University

Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst

Aneurysmal bone cysts (ABCs) are benign, locally destructive growing bone tumors, which were first described in 1942 by Jaffé and Lichtenstein (1). They are most often diagnosed in childhood and early adulthood. The literature reports that ABCs comprise 1-6% of all primary benign bone tumors (2). Most cases of ABCs (75-90%) are reported for patients younger than 20 years, with a slightly higher incidence for females (3). Most common localizations are the pelvis, the metaphysis of long bones and the spine, but ABCs can also affect any other localization(2). ABCs that are associated with a preexisting osseous lesion are defined as secondary ABCs. They represent approximately 30% of all ABCs (2). Secondary ABCs can occur, e.g., in cases of a giant cell tumor, chondroblastoma or telangiectatic osteosarcoma

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The clinical symptoms of an ABC are usually accidently discovered or may consist of pain and swelling in the affected region and pathological fractures ( complete and incomplete ) can be observed occasionally. In conventional radiography a relatively well-defined osteolytic, expansile lesion with possible blowout of the periosteum and a soap-bubble appearance can be found (4). MRI scanning shows cystic formations with typical fluid-fluid levels due to blood sedimentation (7). Because of the possible rapid growth with local destruction, the literature describes cases of ABCs that mimic malignant bone tumors

Study Type

Observational

Enrollment (Actual)

20

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

  • Egypt
      • Assuit, Egypt
        • Faculty of Medicine Al-Azhar University Assuit

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

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

20 Patients complaining from pain at all affected bones. All patients undergo to examination and investigated by radiological (Plain X-rays and MRI).

All patients undergo to C-arm plain X-rays guided biopsy, aspirated histopathology, and Chemical study ( as Alkaline Phosphatase assessment ) as pre-operative planning.

All patients received an injection of polidocanol intralesional as standard treatment with a dose: 2- 4 mg / Kg .

Ossification ( healing ) was assessed on plain X-ray, and the pain was evaluated on a visual analog scale (VAS).

Description

Inclusion Criteria:

  • All Patients above age of 1 year.
  • The affected area was all bones except skull, ribs, and other non-orthopedic specialties.
  • Primary or recurrent ABC
  • Incomplete Fractured affected bones as greenstick fracture.
  • Healed Pathological fracture without any surgical intervention

Exclusion Criteria:

  • ABC. In skull, ribs, and other non-orthopedic specialties.
  • Age less than 1 year
  • Suspected malignancy or other bone cysts
  • Complete fractured bones and healed pathological fracture with surgical intervention.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
sclerotherapy and bone marrow
Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst
Procedure: Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst
Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing
Time Frame: 1 year
Results will discuss in this study, according to assessment of ABC healing ( complete or not ) , and also following assessment of recurrence rate and incidence of complication.
1 year

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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.

General Publications

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)

March 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 8, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SABMIMABC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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