Simple Bone CystNCT03724630
The Results of Multiple Aspirations and Injections of Unicameral Bone Cyst by Methyl Prednisolone Acetate
An observational study of Simple Bone Cyst, run by Assiut University.
Trial summary
Evaluation of the efficacy of methyl prednisolone injection in treatment o f simple bone cyst to prevent all possible complications as pathological fractures and to avoid prolonged restriction of physical activity Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Simple Bone Cyst
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Mar 2020
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Each patient will receive a maximum of three or four injections, with at least three months between injections. The indication for a second or third injection will be based on the surgeon's judgment regarding whether the cyst will be healed or not.. Injections will be performed with the patient under general anesthesia. Under image intensifier. The diagnosis of a unicameral bone cyst will be confirmed by needle aspiration of clear or straw-colored fluid. * Methylprednisolone acetate, 3 mg/cm3 of cyst volume with amaximum dose of 180 mg will be injected into the cyst . If the cyst was multilocular, each cavity will be injected separately follow up of patients by radiological and clinical outcomes
Who may be able to join
- age .: all children eighteen years of age or younger with unicameral bone cyst
- Patient with previous fracture on top of unicameral bone cyst
Who cannot join
- patient age more than 18 years old
- patients with malignant tumors
- patients on chronic steroid treatment
- pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Evaluation of the efficacy of methyl prednisolone injection in treatment o f simple bone cyst to prevent all possible complications as pathological fractures and to avoid prolonged restriction of physical activity
Read the detailed description
unicameral bone cysts (UBCs) are benign, fluid-filled cavities that develop in tubular and flat bones (eg,humerus, femur). These cysts tend to expand and weaken the local bone,but they are not true neoplasms. In 1876, Virchow1 first described these lesions as cystic structures caused by abnormalities in local circulation.
UBCs are also known as simple or solitary bone cysts. They occur almost exclusively in children and adolescents (up to 85% of cases), with a reported peak between ages 3 and14 years and the average age at diagnosis being 9 years.
These lesions represent approximately 3% of all bone tumors and occur more commonly in boys than in girls (2:1). Several treatment options exist for unicameral bone cysts (UBCs), including observation, steroid injection, bone marrow injection, and Surgical procedures have ranged from simple curettage with autologous bone graft or allograft to sub periosteal resection with internal fixation and grafting
.Treatment by multiple injection of steroids produce minimal surgical approach, no hospital stay, and very low morbidity. Three or four injections over a period of 12 month may be enough
- Conditions
- Simple Bone Cyst
- Medical subject headings
- Bone Cysts
What is being measured
The primary outcome is the main question the study is designed to answer.
radiological healing of simple bone cyst
- Modified Neer classification
- Healed cyst : Cyst filled by new bone, with or without small radiolucent area(s) < 1 cm in size
- Healing with defect: Radiolucent area(s) < 50% of the diameter of bone, with enough cortical thickness to prevent fracture
- Persistent cyst: Radiolucent area > 50% of diameter of the bone and with a thin cortical rim. No increase in the size of the cyst. Continued restriction of activity or repeated treatment is required
- Recurrent cyst: Cyst reappeared in a previously obliterated area, or a residual radiolucent area has increased in size
- the cyst index which predict the risk of pathological fracture .The cyst index can be calculated as the area of the cyst divided by the square of the diaphysis diameter cyst index equal to or greater than 3.5 indicates a high fracture risk
Measured: one month after injection
Secondary outcomes (1)
improvement of symptoms
clinical healing by asking the patient or his relevant about improvement of symptoms
Measured: one month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Simple Bone CystStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, michael moured, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724630
- Sponsor's protocol ID
- Assuit University 8000
- Status last verified
- May 2018
- First submitted
- 15 May 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: radiological follow up of patients after one month of injection follow up again by x.ray after three months clinical outcome of patients after injection by visual analogue scale of pain
Publications
Al-Aubaidi Z, Pedersen NW. A bone cyst treated with corticosteroid installation in an osteopetrotic child. J Pediatr Orthop. 2010 Mar;30(2):206-7. doi: 10.1097/BPO.0b013e3181cfcd63.
PubMed 20179571Pavone V, Caff G, Di Silvestri C, Avondo S, Sessa G. Steroid injections in the treatment of humeral unicameral bone cysts: long-term follow-up and review of the literature. Eur J Orthop Surg Traumatol. 2014 May;24(4):497-503. doi: 10.1007/s00590-013-1211-4. Epub 2013 Apr 3.
PubMed 23549913Canavese F, Wright JG, Cole WG, Hopyan S. Unicameral bone cysts: comparison of percutaneous curettage, steroid, and autologous bone marrow injections. J Pediatr Orthop. 2011 Jan-Feb;31(1):50-5. doi: 10.1097/BPO.0b013e3181ff7510.
PubMed 21150732Wright JG, Yandow S, Donaldson S, Marley L; Simple Bone Cyst Trial Group. A randomized clinical trial comparing intralesional bone marrow and steroid injections for simple bone cysts. J Bone Joint Surg Am. 2008 Apr;90(4):722-30. doi: 10.2106/JBJS.G.00620.
PubMed 18381307Yilmaz G, Aksoy MC, Alanay A, Yazici M, Alpaslan AM. [Treatment of simple bone cysts with methylprednisolone acetate in children]. Acta Orthop Traumatol Turc. 2005;39(5):411-5. Turkish.
PubMed 16531698Goel AR, Kriger J, Bronfman R, Lauf E. Unicameral bone cysts: treatment with methylprednisone acetate injections. J Foot Ankle Surg. 1994 Jan-Feb;33(1):6-15.
PubMed 8161995Rud B, Pedersen NW, Thomsen PB. Simple bone cysts in children treated with methylprednisolone acetate. Orthopedics. 1991 Feb;14(2):185-7. doi: 10.3928/0147-7447-19910201-15.
PubMed 2008387Farber JM, Stanton RP. Treatment options in unicameral bone cysts. Orthopedics. 1990 Jan;13(1):25-32. doi: 10.3928/0147-7447-19900101-06.
PubMed 2300515
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Results of Multiple Aspirations and Injections of Unicameral Bone Cyst by Methyl Prednisolone Acetate
- ClinicalTrials.gov ID
- NCT03724630
- Acronym / sponsor ID
- Assuit University 8000
- Conditions
- Simple Bone Cyst
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 30 Oct 2018 (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.
Evaluation of the efficacy of methyl prednisolone injection in treatment o f simple bone cyst to prevent all possible complications as pathological fractures and to avoid prolonged restriction of physical activity
Detailed description
unicameral bone cysts (UBCs) are benign, fluid-filled cavities that develop in tubular and flat bones (eg,humerus, femur). These cysts tend to expand and weaken the local bone,but they are not true neoplasms. In 1876, Virchow1 first described these lesions as cystic structures caused by abnormalities in local circulation.
UBCs are also known as simple or solitary bone cysts. They occur almost exclusively in children and adolescents (up to 85% of cases), with a reported peak between ages 3 and14 years and the average age at diagnosis being 9 years.
These lesions represent approximately 3% of all bone tumors and occur more commonly in boys than in girls (2:1). Several treatment options exist for unicameral bone cysts (UBCs), including observation, steroid injection, bone marrow injection, and Surgical procedures have ranged from simple curettage with autologous bone graft or allograft to sub periosteal resection with internal fixation and grafting
.Treatment by multiple injection of steroids produce minimal surgical approach, no hospital stay, and very low morbidity. Three or four injections over a period of 12 month may be enough
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Each patient will receive a maximum of three or four injections, with at least three months between injections. The indication for a second or third injection will be based on the surgeon's judgment regarding whether the cyst will be healed or not.. Injections will be performed with the patient under general anesthesia. Under image intensifier. The diagnosis of a unicameral bone cyst will be confirmed by needle aspiration of clear or straw-colored fluid. * Methylprednisolone acetate, 3 mg/cm3 of cyst volume with amaximum dose of 180 mg will be injected into the cyst . If the cyst was multilocular, each cavity will be injected separately follow up of patients by radiological and clinical outcomes
Key inclusion criteria (2 listed)
- age .: all children eighteen years of age or younger with unicameral bone cyst
- Patient with previous fracture on top of unicameral bone cyst
Key exclusion criteria (4 listed)
- patient age more than 18 years old
- patients with malignant tumors
- patients on chronic steroid treatment
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
radiological healing of simple bone cyst
Time frame: one month after injection
1. Modified Neer classification 1. Healed cyst : Cyst filled by new bone, with or without small radiolucent area(s) < 1 cm in size 2. Healing with defect: Radiolucent area(s) < 50% of the diameter of bone, with enough cortical thickness to prevent fracture 3. Persistent cyst: Radiolucent area > 50% of diameter of the bone and with a thin cortical rim. No increase in the size of the cyst. Continued restriction of activity or repeated treatment is required 4. Recurrent cyst: Cyst reappeared in a previously obliterated area, or a residual radiolucent area has increased in size 2. the cyst index which predict the risk of pathological fracture .The cyst index can be calculated as the area of the cyst divided by the square of the diaphysis diameter cyst index equal to or greater than 3.5 indicates a high fracture risk
1 secondary outcome
improvement of symptoms
Time frame: one month after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Background: PubMed 20179571Al-Aubaidi Z, Pedersen NW. A bone cyst treated with corticosteroid installation in an osteopetrotic child. J Pediatr Orthop. 2010 Mar;30(2):206-7. doi: 10.1097/BPO.0b013e3181cfcd63.
- Background: PubMed 23549913Pavone V, Caff G, Di Silvestri C, Avondo S, Sessa G. Steroid injections in the treatment of humeral unicameral bone cysts: long-term follow-up and review of the literature. Eur J Orthop Surg Traumatol. 2014 May;24(4):497-503. doi: 10.1007/s00590-013-1211-4. Epub 2013 Apr 3.
- Background: PubMed 21150732Canavese F, Wright JG, Cole WG, Hopyan S. Unicameral bone cysts: comparison of percutaneous curettage, steroid, and autologous bone marrow injections. J Pediatr Orthop. 2011 Jan-Feb;31(1):50-5. doi: 10.1097/BPO.0b013e3181ff7510.
- Background: PubMed 18381307Wright JG, Yandow S, Donaldson S, Marley L; Simple Bone Cyst Trial Group. A randomized clinical trial comparing intralesional bone marrow and steroid injections for simple bone cysts. J Bone Joint Surg Am. 2008 Apr;90(4):722-30. doi: 10.2106/JBJS.G.00620.
- Background: PubMed 16531698Yilmaz G, Aksoy MC, Alanay A, Yazici M, Alpaslan AM. [Treatment of simple bone cysts with methylprednisolone acetate in children]. Acta Orthop Traumatol Turc. 2005;39(5):411-5. Turkish.
- Background: PubMed 8161995Goel AR, Kriger J, Bronfman R, Lauf E. Unicameral bone cysts: treatment with methylprednisone acetate injections. J Foot Ankle Surg. 1994 Jan-Feb;33(1):6-15.
- Background: PubMed 2008387Rud B, Pedersen NW, Thomsen PB. Simple bone cysts in children treated with methylprednisolone acetate. Orthopedics. 1991 Feb;14(2):185-7. doi: 10.3928/0147-7447-19910201-15.
- Background: PubMed 2300515Farber JM, Stanton RP. Treatment options in unicameral bone cysts. Orthopedics. 1990 Jan;13(1):25-32. doi: 10.3928/0147-7447-19900101-06.
- Individual participant dataSharing planned: Undecided. radiological follow up of patients after one month of injection follow up again by x.ray after three months clinical outcome of patients after injection by visual analogue scale of pain
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Simple Bone Cyst, run by Assiut University.
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 2 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 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact michael M. gerges (01201885642, madred_man72@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiological healing of simple bone cyst (time frame: one month after injection). 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 NCT03724630, which also lists 8 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 30 Oct 2018.