Sclerotherapy and Bone Marrow Injection In Aneurysmal Bone Cyst

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05696834
• Other study ID #: SABMIMABC
• Status: Active, not recruiting
• Start date: March 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Cysts
• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Al-Azhar University Assuit	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Dormans JP, Hanna BG, Johnston DR, Khurana JS. Surgical treatment and recurrence rate of aneurysmal bone cysts in children. Clin Orthop Relat Res. 2004 Apr;(421):205-11. doi: 10.1097/01.blo.0000126336.46604.e1. — View Citation

Shiels WE 2nd, Mayerson JL. Percutaneous doxycycline treatment of aneurysmal bone cysts with low recurrence rate: a preliminary report. Clin Orthop Relat Res. 2013 Aug;471(8):2675-83. doi: 10.1007/s11999-013-3043-2. Epub 2013 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing	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