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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C & P | Active Comparator | Curettage with puncture (C & P) will be performed alone |
|
| C & P with Vitoss | Active Comparator | A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C & P) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curettage with puncture (C & P) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cyst healing | Healing will be graded according to a 4-point modified Neer's classification by radiologists | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical measures (Cyst features) | Cyst features (ie. appearance, size) will be described or measured from X-rays taken annually after treatment | 1 and 2 years |
| Functional measures (Questionnaire scores) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Contact | sbock.study@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| James G. Wright | The Hospital for Sick Children | Principal Investigator |
| Sevan Hopyan | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Withdrawn | Birmingham | Alabama | 35233 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18381307 | Background | 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. | |
| 21191299 | Background | 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. |
| Label | URL |
|---|---|
| SBoCK Trial Website | View source |
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| Curette | Device | A small surgical instrument with a rounded edge designed for scraping |
|
| Vitoss morsels | Device | A bone substitute intended for use as a filler for voids or gaps in bones |
|
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Function in participants will be evaluated using self-reported questionnaires for activity level, perception of illness, and pain annually after treatment
| 1 and 2 years |
| Loma Linda University |
| Recruiting |
| Loma Linda |
| California |
| 92354 |
| United States |
|
| Nemours/Alfred I. duPont Hospital for Children | Completed | Wilmington | Delaware | 19803 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
|
| The John Hopkins Hospital | Withdrawn | Baltimore | Maryland | 21287 | United States |
| Hospital for Joint Diseases | Withdrawn | New York | New York | 10003 | United States |
| Hospital for Special Surgery | Withdrawn | New York | New York | 10021 | United States |
| The Children's Hospital at Montefiore | Completed | The Bronx | New York | 10467 | United States |
| University of North Carolina - Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
|
| Cincinnati Children's Hospital Medical Center | Completed | Cincinnati | Ohio | 45229 | United States |
| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
|
| The Royal Children's Hospital | Recruiting | Melbourne | Australia |
|
| Alberta Children's Hospital | Recruiting | Calgary | Alberta | T3B 6A8 | Canada |
|
| BC Children's Hospital | Recruiting | Vancouver | British Columbia | V6H 3V4 | Canada |
|
| Winnipeg Health Sciences Centre | Withdrawn | Winnipeg | Manitoba | R3A 1R9 | Canada |
| IWK Health Centre | Recruiting | Halifax | Nova Scotia | B3K 6R8 | Canada |
|
| Children's Hospital at London Health Sciences Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
|
| Children's Hospital of Eastern Ontario | Recruiting | Ottawa | Ontario | K1H 8L1 | Canada |
|
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
|
| Shriners Hospital for Children - Canadian Unit | Completed | Montreal | Quebec | H3G 1A6 | Canada |
| Alder Hey Children's Hospital | Recruiting | Liverpool | L12 2AP | United Kingdom |
|
| Great Ormond Street Hospital for Children | Recruiting | London | WC1N 3JH | United Kingdom |
|
| Royal Manchester Children's Hospital | Recruiting | Manchester | M13 9WL | United Kingdom |
|
| Nuffield Orthopaedic Centre | Recruiting | Oxford | OX3 7HE | United Kingdom |
|
| Sheffield Children's Hospital | Recruiting | Sheffield | S10 2TH | United Kingdom |
|
| 21150732 | Background | 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. |
| 21808696 | Background | 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. |
| ID | Term |
|---|---|
| D001845 | Bone Cysts |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003475 | Curettage |
| D011677 | Punctures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
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