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Trial record 3 of 21 for:    "Bone Disease" | "Prednisolone phosphate"

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

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ClinicalTrials.gov Identifier: NCT03724630
Recruitment Status : Not yet recruiting
First Posted : October 30, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
michael moured, Assiut University

Tracking Information
First Submitted Date May 15, 2018
First Posted Date October 30, 2018
Last Update Posted Date October 30, 2018
Estimated Study Start Date January 1, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 28, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 28, 2018)
improvement of symptoms [ Time Frame: one month after injection ]
clinical healing by asking the patient or his relevant about improvement of symptoms
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition Simple Bone Cyst
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: October 28, 2018)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: michael M. gerges 01201885642 madred_man72@yahoo.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03724630
Other Study ID Numbers Assuit University 8000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: 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
Responsible Party michael moured, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date May 2018