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

• Conditions: Simple Bone Cyst

• Registration Number: NCT03724630
• Lead Sponsor: Assiut University

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

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-10-28
• Last Update Submitted: 2018-10-28
• Study First Posted: 2018-10-30
• Last Update Posted: 2018-10-30
• Study Start: 2019-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
radiological healing of simple bone cyst	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

Secondary Outcome Measures

Name	Time	Method
improvement of symptoms	one month after injection	clinical healing by asking the patient or his relevant about improvement of symptoms