Simple Bone Cysts in Kids

Официальное название

Simple Bone Cysts in Kids (SBoCK)

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Устройство Curette
  A small surgical instrument with a rounded edge designed for scraping
• Устройство Vitoss morsels
  A bone substitute intended for use as a filler for voids or gaps in bones

Первичные конечные точки

• Cyst healing [Срок оценки: 2 years]

Вторичные конечные точки (2)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 11 центров

• 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
• … и ещё 3 центра

Канада · 8 центров

• 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

Великобритания · 5 центров

• 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

Австралия · 1 центр

• The Royal Children's Hospital — Melbourne

Публикации

• 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

Идентификаторы

NCT: NCT02193841 · 1000042364

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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