Clinical trial NCT03724630: The Results of Multiple Aspirations and Injections of Unicameral Bone Cyst by Methyl Prednisolone Acetate
Official title: The Results of Multiple Aspirations and Injections of Unicameral Bone Cyst by Methyl Prednisolone Acetate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Simple Bone Cyst
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 15
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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

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

Eligibility criteria: 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:

* patient age more than 18 years old
* patients with malignant tumors
* patients on chronic steroid treatment
* pregnancy

Primary outcomes:
measure: radiological healing of simple bone cyst
timeFrame: one month after injection
Secondary outcomes:
measure: improvement of symptoms
timeFrame: one month after injection
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Farber JM, Stanton RP. Treatment options in unicameral bone cysts. Orthopedics. 1990 Jan;13(1):25-32. doi: 10.3928/0147-7447-19900101-06.