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Trial Title:
Sclerotherapy and Bone Marrow Injection In Aneurysmal Bone Cyst
NCT ID:
NCT05696834
Condition:
Orthopedic Disorder
Conditions: Official terms:
Bone Cysts
Bone Cysts, Aneurysmal
Musculoskeletal Diseases
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst
Description:
Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst
Arm group label:
sclerotherapy and bone marrow
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
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
Criteria for eligibility:
Study pop:
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).
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
1 Year
Maximum age:
N/A
Locations:
Facility:
Name:
Faculty of Medicine Al-Azhar University Assuit
Address:
City:
Assuit
Country:
Egypt
Start date:
March 1, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Al-Azhar University
Agency class:
Other
Source:
Al-Azhar University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05696834