NCT05696834

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

January 8, 2023

Last Update Submit

October 9, 2023

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

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

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

sclerotherapy and bone marrow

Eligibility Criteria

Age1 Year+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Al-Azhar University Assuit

Asyut, Egypt

Location

Related 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.

    PMID: 15123949BACKGROUND

  • 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.

    PMID: 23670673BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Sclerotherapy

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 25, 2023

Study Start

March 1, 2023

Primary Completion

January 1, 2025

Study Completion

December 1, 2025

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)