Sclerotherapy and Bone Marrow Injection In Aneurysmal Bone Cyst

Sponsor
Al-Azhar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05696834
Collaborator
(none)
20
33.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Healing [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdallah Mousa Elwany Hassan, principal investigator, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05696834
Other Study ID Numbers:
  • SABMIMABC
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2023