Surgical Treatments for Bone Cysts
(SBoCK Trial)
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: The Hospital for Sick Children
Disqualifiers: Bone disease, Pregnant, Growth plate, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment for bone cysts?
Research shows that using ultraporous β-tricalcium phosphate (Vitoss) as a bone graft after curettage (surgical scraping) is effective in healing bone voids, with most patients experiencing complete or near-complete healing within 6 months. Additionally, combining curettage with bone marrow aspirate may speed up the healing process.
12345Is the surgical treatment for bone cysts using synthetic bone grafts safe?
Studies show that using synthetic bone grafts like ultraporous β-tricalcium phosphate (Vitoss) and GeneX for treating bone cysts is generally safe, with no reported infections or adverse reactions. Patients typically experience healing and can resume daily activities without complications.
12367How is the treatment Curettage with puncture (C & P) for bone cysts different from other treatments?
Curettage with puncture (C & P) is unique because it combines the removal of cyst tissue with the use of Vitoss, a synthetic bone graft that helps support bone healing. This approach is different from other treatments like sclerotherapy or steroid injections, which do not involve direct removal of the cyst or the use of a bone graft to aid in recovery.
4891011Eligibility Criteria
This trial is for kids with simple bone cysts in their arms or legs. They must have had the cyst confirmed within the last 3 months and not treated it recently. Kids who've had a fracture need to wait at least 3 weeks before joining. It's not for pregnant teens, those breastfeeding, or anyone with other bone diseases.Inclusion Criteria
I have a confirmed simple bone cyst in my arm or leg diagnosed in the last 3 months.
It has been over 3 weeks since my last bone fracture.
Patients and/or their legal representatives willing to provide written informed consent (and assent, when appropriate)
+2 more
Exclusion Criteria
I have a bone condition such as osteoporosis or bone cancer.
Pregnant or breastfeeding female
I have cysts that extend across the area of bone growth.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive one of two treatments: curettage with puncture alone or curettage with puncture followed by injection with Vitoss morsels
Not specified
Follow-up
Participants are monitored for cyst healing and functional measures using radiographic and questionnaire assessments
2 years
Annual visits for assessments
Participant Groups
The study compares two treatments: 'Curettage with puncture' where surgeons scrape out the cyst and make a hole for drainage, and using 'Vitoss morsels', which are synthetic bone graft materials placed into the cavity after scraping.
2Treatment groups
Active Control
Group I: C & P with VitossActive Control3 Interventions
A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)
Group II: C & PActive Control2 Interventions
Curettage with puncture (C \& P) will be performed alone
Curettage with puncture (C & P) is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Curettage with puncture for:
- Simple bone cysts
- Unicameral bone cysts
🇺🇸 Approved in United States as Curettage with puncture for:
- Simple bone cysts
- Unicameral bone cysts
🇨🇦 Approved in Canada as Curettage with puncture for:
- Simple bone cysts
- Unicameral bone cysts
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Hospital for Sick ChildrenToronto, Canada
BC Children's HospitalVancouver, Canada
IWK Health CentreHalifax, Canada
University of North Carolina - Chapel HillChapel Hill, NC
More Trial Locations
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Who Is Running the Clinical Trial?
The Hospital for Sick ChildrenLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
Ultraporous β-tricalcium phosphate alone or combined with bone marrow aspirate for benign cavitary lesions: comparison in a prospective randomized clinical trial. [2022]Ultraporous β-tricalcium phosphate (TCP) synthetic graft material (Vitoss; Orthovita) persists for a year or longer in some cases. In this study, we prospectively examined healing of cavitary defects filled with TCP versus TCP and bone marrow aspirate (TCP/BM) with the hypothesis that bone-marrow aspirate speeds incorporation of bone graft substitute.
Effectiveness of ultraporous β-tricalcium phosphate (vitoss) as bone graft substitute for cavitary defects in benign and low-grade malignant bone tumors. [2022]We retrospectively evaluated healing with ultraporous β-tricalcium phosphate (β-TCP [Vitoss; Orthovida, Malvern, Pennsylvania]) bone graft in patients who underwent surgical excision or curettage of benign bone lesions subsequently filled with bone void filler. Twentynine patients were treated with curettage and ultraporous β-TCP morsels. Radiologic defect size at initial postoperative presentation and subsequent visits (minimum follow-up, 6 months) was evaluated. Results suggested that an ultraporous β-TCP synthetic bone graft is effective in managing bone voids. The vast majority of patients who undergo curettage for benign bone lesions can expect to have complete or near complete healing of these defects within 6 months of their surgical procedure with use of ultraporous β-TCP morsels.
Simple bone cysts. A review of 59 cases with special reference to their treatment. [2020]In a retrospective study, 21 simple bone cysts (SBC) treated by curettage (with or without bone grafting) are compared to 20 SBC treated by intralesional injections of methylprednisolone. Curettage led to 43% favourable results and 29% recurrences. Cortisone injections led to 90% favourable results and 5% recurrences. Combined therapy (curettage and injections) led to results comparable to injections only. In our experience, curettage and hydroxyapatite grafting led to 100% complete healing (only 2 cases). We recommend intralesional methylprednisolone injections because the method is easy, effective and safe.
Treatment of simple bone cysts using endoscopic curettage: a case series analysis. [2022]Endoscopic curettage is considered applicable for the treatment of simple bone cysts with the expectation that it might be less invasive than open curettage. In this study, we investigated the efficacy of endoscopic curettage for the treatment of simple bone cysts. The goal was to investigate the incidence of cyst recurrence and bone healing after endoscopic curettage. Moreover, complications and functionality at the final follow-up were evaluated.
Curettage of benign bone tumors and tumor like lesions: A retrospective analysis. [2022]Curettage is one of the most common treatment options for benign lytic bone tumors and tumor like lesions. The resultant defect is usually filled. We report our outcome curettage of benign bone tumors and tumor like lesions without filling the cavity.
Use of purified beta-tricalcium phosphate for filling defects after curettage of benign bone tumours. [2022]Fifty-three patients with benign bone tumours were treated with curettage and filling with a purified beta-tricalcium phosphate (beta-TCP). Recurrences occurred in two cases. There was neither a postoperative infection nor adverse reaction due to the material. Postoperative fractures did not occur in any patients. Radiographically, complete resorption of the material and bone remodelling were achieved in 23 cases (43%). Of these 23 cases, there was a statistical correlation between the filling volume and the time taken for complete resorption (p
Injectable Synthetic Beta-Tricalcium Phosphate/Calcium Sulfate (GeneX) for the Management of Contained Defects Following Curettage of Benign Bone Tumours. [2023]Benign and low-grade malignant bone tumours are often treated with curettage and filling of the resultant defect using any of a number of materials, including autologous bone grafts, allografts, or synthetic materials. The objective of this study was to report our experience using a synthetic bone graft substitute in these patients. Ten consecutive cases (four males, six females; mean age, 36 years) of benign bone tumours were treated surgically at a tertiary musculoskeletal oncology centre, between 2019 and 2021. Following curettage, the contained defects were managed with injectable beta-tricalcium phosphate/calcium sulfate (GeneX; Biocomposites Ltd., Keele, UK). The desired outcomes were early restoration of function and radiographic evidence of healing. No other graft materials were used in any of the patients. The mean follow-up was 24 months (range, 20-30 months). All patients in this series (100%) demonstrated radiographic evidence of healing and resumed their daily living activities. There were no tumour recurrences and no complications were encountered with the use of GeneX. In patients with contained defects following curettage of benign bone tumours, we found GeneX to be a safe and effective filling agent. These findings contrast with some existing studies that have reported local complications with the use of injectable beta-tricalcium phosphate/calcium sulfate.
Elastic Stable Intramedullary Nailing (ESIN), Orthoss® and Gravitational Platelet Separation--System (GPS®): an effective method of treatment for pathologic fractures of bone cysts in children. [2021]The different treatment strategies for bone cysts in children are often associated with persistence and high recurrence rates of the lesions. The safety and clinical outcomes of a combined mechanical and biological treatment with elastic intramedullary nailing, artificial bone substitute and autologous platelet rich plasma are evaluated.
Is sclerotherapy with polidocanol a better treatment option for aneurysmal bone cyst compared to conventional curettage and bone grafting? [2022]The standard treatment of Aneurysmal bone cyst is curettage and grafting and is associated with high morbidity. Hence minimal invasive alternative treatment methods such as sclerotherapy are gaining much popularity. Though sclerotherapy has been attributed to reasonable cure rates, undetermined tissue diagnosis often impedes with initiation of treatment. This study examines if sclerotherapy with polidocanol based on clinic-radiological picture is comparable with the standard intralesional curettage and bone grafting. Attempting biopsy and treatment simultaneously based on the clinico-radiological presentation makes this study unique.
Unicameral (simple) and aneurysmal bone cysts: the effect of insufficient curettage on recurrence. [2018]Curettage of the cyst and bone grafting are the most common methods used in the treatment of unicameral bone cysts (UBC) and aneurysmal bone cysts (ABC). Recurrence of these cysts is often associated with insufficient curettage of the cyst during surgery. In this study, we aimed to evaluate the effect of insufficient curettage on recurrence in patients with UBC and ABC.
[Treatment of solitary bone cysts by intra-medullary nailing or steroid injection in children]. [2013]Several methods are used to treat essential bone cysts in children: curettage with bone graft, simple drainage, steroid injection, intramedullary nailing. No one method is preferred by all. We compared two retrospective series of children with solitary bone cysts treated by steroid injection or intramedullary nailing.