Orthopedic DisorderNCT05696834
Sclerotherapy and Bone Marrow Injection In Aneurysmal Bone Cyst
An observational study of Orthopedic Disorder, run by Al-Azhar University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Orthopedic Disorder
- Being tested
- Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone CystProcedure or surgery
Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst
| Study group | Role | What they receive |
|---|---|---|
| sclerotherapy and bone marrow | Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst Receives: Procedure: Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Mar 2023
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Mousa Elwany Hassan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696834
- Sponsor's protocol ID
- SABMIMABC
- Status last verified
- Oct 2023
- First submitted
- 8 Jan 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15123949Shiels 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.
PubMed 23670673
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst
- ClinicalTrials.gov ID
- NCT05696834
- Acronym / sponsor ID
- SABMIMABC
- Conditions
- Orthopedic Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sclerotherapy and bone marrow | – | Procedure: Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone CystSclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone CystSclerotherapy With Adjuvant Bone Marrow Injection In Management of Aneurysmal Bone Cyst | Procedure or surgery | sclerotherapy and bone marrow |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Background: PubMed 15123949Dormans 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.
- Background: PubMed 23670673Shiels 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696834, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.