Simple Bone Cysts in Kids

Official title

Simple Bone Cysts in Kids (SBoCK)

Overview

Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today.

Detailed description

In general, few randomized clinical trials have been undertaken in paediatric orthopaedics, and only one to date has addressed the problem of simple bone cysts (SBCs). Also known as unicameral bone cysts, they are the commonest bone lesion in children. Despite general opinion, these cysts do not resolve at skeletal maturity.

Many forms of treatment have been recommended but none, including the popular methods of corticosteroid or bone marrow injections, have reliably eradicated SBC. Although the lesions are considered benign (non-cancerous), they cause pain, frequently interfere with function, dramatically restrict play activity, may re-fracture leading to growth arrest and/or deformity, and cause enormous anxiety for children and their families.

With a well-developed network of surgeons and researchers, we will provide evidence comparing the effectiveness of two treatment interventions for SBC. More specifically, our goals for this study are:

1. to compare the rate of radiographic healing between two standard treatments including curettage with puncture alone, and curettage with puncture followed by injection with Vitoss morsels; 2. to identify prognostic radiographic factors associated with simple bone cyst healing and fracture; 3. to determine the impact of simple bone cyst on children/family functioning.

Interventions

• Procedure Curettage with puncture (C & P)
  A curette will be inserted to scrape the contents of the cyst (curettage) and a hole in the cyst wall will be made (puncture) near the bone marrow cavity
• Device Curette
  A small surgical instrument with a rounded edge designed for scraping
• Device Vitoss morsels
  A bone substitute intended for use as a filler for voids or gaps in bones

Primary outcome measures

• Cyst healing [Time frame: 2 years]

Secondary outcome measures (2)

• Clinical measures (Cyst features) [Time frame: 1 and 2 years]
• Functional measures (Questionnaire scores) [Time frame: 1 and 2 years]

Eligibility criteria

Inclusion criteria

• Patients with a confirmed simple bone cyst in a long bone (ie. arm or leg) within last 3 months
• At least 3 weeks must have elapsed since last fracture
• At least 3 months must have elapsed since last cyst treatment
• Patients and/or their legal representatives willing to provide written informed consent (and assent, when appropriate)
• Patients with stabilizing implants in the bone where the cyst is located

Exclusion criteria

• Patients with bone disease (ie. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease)
• Pregnant or breastfeeding female
• Patients with cysts crossing the growth plate (area where bone grows)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 11 centers

• Children's Hospital of Alabama — Birmingham
• Loma Linda University — Loma Linda
• Nemours/Alfred I. duPont Hospital for Children — Wilmington
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• The John Hopkins Hospital — Baltimore
• Hospital for Joint Diseases — New York
• Hospital for Special Surgery — New York
• The Children's Hospital at Montefiore — The Bronx
• … and 3 more centers

Canada · 8 centers

• Alberta Children's Hospital — Calgary
• BC Children's Hospital — Vancouver
• Winnipeg Health Sciences Centre — Winnipeg
• IWK Health Centre — Halifax
• Children's Hospital at London Health Sciences Centre — London
• Children's Hospital of Eastern Ontario — Ottawa
• The Hospital for Sick Children — Toronto
• Shriners Hospital for Children - Canadian Unit — Montreal

United Kingdom · 5 centers

• Alder Hey Children's Hospital — Liverpool
• Great Ormond Street Hospital for Children — London
• Royal Manchester Children's Hospital — Manchester
• Nuffield Orthopaedic Centre — Oxford
• Sheffield Children's Hospital — Sheffield

Australia · 1 center

• The Royal Children's Hospital — Melbourne

Publications

• 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. PMID 18381307
• Donaldson S, Wright JG. Recent developments in treatment for simple bone cysts. Curr Opin Pediatr. 2011 Feb;23(1):73-7. doi: 10.1097/MOP.0b013e3283421111. PMID 21191299
• 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. PMID 21150732
• Donaldson S, Chundamala J, Yandow S, Wright JG. Treatment for unicameral bone cysts in long bones: an evidence based review. Orthop Rev (Pavia). 2010 Mar 20;2(1):e13. doi: 10.4081/or.2010.e13. PMID 21808696

Identifiers

NCT: NCT02193841 · 1000042364

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗