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

Simple Bone Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03724630
• Other study ID #: Assuit University 8000
• Status: Not yet recruiting
• Start date: January 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2018
• Source: Assiut University
• Contact: michael M. gerges
• Phone: 01201885642
• Email: madred_man72[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Cysts
• Cysts
• Simple Bone Cyst

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

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. — View 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. — View Citation

Farber JM, Stanton RP. Treatment options in unicameral bone cysts. Orthopedics. 1990 Jan;13(1):25-32. — View 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. Review. — View 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. Review. — View Citation

Rud B, Pedersen NW, Thomsen PB. Simple bone cysts in children treated with methylprednisolone acetate. Orthopedics. 1991 Feb;14(2):185-7. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one month after injection
Secondary	improvement of symptoms	clinical healing by asking the patient or his relevant about improvement of symptoms	one month after injection