ClinicalTrials.gg
Status unknownNCT03724630Updated Oct 30, 2018

The Results of Multiple Aspirations and Injections of Unicameral Bone Cyst by Methyl Prednisolone Acetate

An observational study in Simple Bone Cyst, sponsored by Assiut University. Status unknown. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-10-30.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
Up to 18 Years
Sex
All
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Study 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 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

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Conditions studied

  • Simple Bone Cyst

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03

In context

Bone Cysts

18 studies on the registry are indexed under Bone Cysts; 5 are open to participants now.

Browse Bone Cysts studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age .: all children eighteen years of age or younger with unicameral bone cyst
  • Patient with previous fracture on top of unicameral bone cyst

Exclusion criteria

Exclusion Criteria:

  • patient age more than 18 years old
  • patients with malignant tumors
  • patients on chronic treatment
  • pregnancy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. radiological healing of simple bone cyst

    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

    Time frame: one month after injection

Secondary outcomes

  1. improvement of symptoms

    clinical healing by asking the patient or his relevant about improvement of symptoms

    Time frame: one month after injection

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Study locations

No study locations are listed for this record.

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References and documents

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 20179571 ↗
  • Pavone 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 23549913 ↗
  • Canavese 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 21150732 ↗
  • Wright 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 18381307 ↗
  • Yilmaz 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 16531698 ↗
  • Goel 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 8161995 ↗
  • Rud 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 2008387 ↗
  • Farber 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 ↗

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03724630
Lead sponsor
Assiut University
Responsible party
michael moured (principal investigator, Assiut University) — Principal investigator
First posted
Oct 30, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Jan 1, 2020 (estimated)
Completion
Mar 1, 2020 (estimated)
Last update
Oct 30, 2018

Study contacts

michael M. gerges
Contact
madred_man72@yahoo.com
01201885642

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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