Surgical Treatments for Bone Cysts

(SBoCK Trial)

Recruiting at 15 trial locations

Overseen By Project Manager

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: The Hospital for Sick Children

Disqualifiers: Bone disease, Pregnant, Growth plate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Not specified

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two surgical treatments for simple bone cysts, fluid-filled sacs often found in the long bones of children. The goal is to determine which treatment is more effective: curettage with puncture alone or curettage with puncture followed by an injection of Vitoss morsels, a bone graft material. It targets individuals diagnosed with a simple bone cyst in the arm or leg within the last three months, with at least three weeks since their last fracture. Those who fit this profile could help identify the most effective treatment by participating. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that curettage with puncture (C & P) is generally safe for treating bone cysts. One study found that about 17% of patients experienced complications, such as infections or minor nerve issues, but these were uncommon. Most patients recovered well after the procedure.

The safety data for Vitoss morsels is also encouraging. Vitoss, a man-made bone graft, is considered safe and effective. It avoids risks like disease transmission or the need for additional surgery sites, making it a safer choice compared to some other options.

Both treatments are well-tolerated and have been used successfully in other cases, demonstrating their general safety for treating bone cysts. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for bone cysts because they offer a potential improvement over traditional methods like curettage and bone grafting. The unique feature of Curettage with puncture (C & P) combined with Vitoss morsels is the use of synthetic bone graft material (Vitoss) that gets injected after the procedure. This could enhance bone healing and fill cystic cavities more effectively than using only the body's natural healing process. By providing a scaffold for new bone growth, Vitoss might accelerate recovery and improve outcomes compared to standard care.

What evidence suggests that this trial's treatments could be effective for simple bone cysts?

Research has shown that curettage with puncture (C & P) often successfully treats simple bone cysts by controlling the cyst and promoting bone healing. In this trial, one group of participants will receive C & P alone, while another group will receive C & P combined with Vitoss morsels, a synthetic bone graft. Studies confirm that Vitoss supports bone growth and healing after surgery. Combining C & P with Vitoss offers a promising treatment for bone cysts by providing support and aiding proper bone healing. ^{1 2 6 7 8}

Who Is on the Research Team?

Sevan Hopyan

Principal Investigator

The Hospital for Sick Children

James G. Wright

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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)

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Curettage with puncture (C & P)
• Curette
• Vitoss morsels

Trial Overview 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.

How Is the Trial Designed?

Group I: C & P with Vitoss Active Control 3 Interventions

A predetermined amount of Vitoss morsels will be injected following the curettage and puncture (C \& P)

Group II: C & P Active Control 2 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

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a study of 42 patients with benign bone tumors, curettage without filling the cavity resulted in most bone defects completely reconstituting to normal, demonstrating the bone's natural healing ability.

While some patients experienced fractures, all healed well, and local recurrence was low, suggesting that extended curettage alone can be an effective treatment for certain benign lytic tumors without the need for grafting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Curettage of benign bone tumors and tumor like lesions: A retrospective analysis. Kundu, ZS., Gupta, V., Sangwan, SS., et al.[2022]

A combined treatment approach using elastic intramedullary nailing, artificial bone substitute, and autologous platelet rich plasma was evaluated in 12 children with bone cysts, showing no complications and effective outcomes.

At follow-up, 10 out of 12 patients had complete resolution of their cysts, and all patients returned to normal activities without any refractures, indicating the efficacy of this treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rapp, M., Svoboda, D., Wessel, LM., et al.[2021]

In a study of 32 patients (18 with unicameral bone cysts and 14 with aneurysmal bone cysts), recurrence of these cysts was linked to insufficient curettage during the initial surgery, highlighting the importance of thorough surgical technique.

Patients who experienced recurrence and underwent a second curettage and grafting procedure achieved complete healing, suggesting that proper treatment can effectively resolve the issue of recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unicameral (simple) and aneurysmal bone cysts: the effect of insufficient curettage on recurrence. Çelik, S., Uludağ, A., Tosun, HB., et al.[2018]

In a study of 55 patients with benign bone lesions, both ultraporous β-tricalcium phosphate (TCP) and TCP combined with bone marrow aspirate (TCP/BM) showed significant improvements in bone healing over a follow-up period of up to 24 months, indicating the effectiveness of TCP as a bone graft substitute.

However, the addition of bone marrow aspirate did not provide any significant advantages in healing compared to TCP alone, suggesting that TCP is sufficient for promoting bone incorporation without the need for additional materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultraporous β-tricalcium phosphate alone or combined with bone marrow aspirate for benign cavitary lesions: comparison in a prospective randomized clinical trial. Damron, TA., Lisle, J., Craig, T., et al.[2022]

In a study of 29 patients who underwent surgical excision or curettage of benign bone lesions, the use of ultraporous β-tricalcium phosphate (β-TCP) bone graft showed effective healing of bone voids.

Most patients experienced complete or near-complete healing of their bone defects within 6 months post-surgery, indicating that β-TCP is a reliable option for managing these types of bone lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of ultraporous β-tricalcium phosphate (vitoss) as bone graft substitute for cavitary defects in benign and low-grade malignant bone tumors. Van Hoff, C., Samora, JB., Griesser, MJ., et al.[2022]

In a study of 53 patients with benign bone tumors, treatment with curettage and purified beta-tricalcium phosphate (beta-TCP) showed no postoperative infections or adverse reactions, indicating its safety as a bone graft substitute.

The study found that beta-TCP led to complete resorption and bone remodeling in 43% of cases, with a significant correlation between the volume of the filling and the time for complete resorption, highlighting its efficacy in promoting bone healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of purified beta-tricalcium phosphate for filling defects after curettage of benign bone tumours. Hirata, M., Murata, H., Takeshita, H., et al.[2022]

Endoscopic curettage for simple bone cysts showed an 81.1% success rate in preventing recurrence, with only 18.9% of patients experiencing recurrence, particularly linked to contact with the growth plate (physis).

The procedure was minimally invasive, with 83.7% of patients achieving bone healing within an average of 4 months, and while some complications occurred, they were manageable and did not significantly affect overall postoperative function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of simple bone cysts using endoscopic curettage: a case series analysis. Aiba, H., Kobayashi, M., Waguri-Nagaya, Y., et al.[2022]

In a study of 48 patients with aneurysmal bone cysts, percutaneous sclerotherapy using polidocanol achieved a 100% healing rate compared to 82% for traditional curettage and bone grafting, with no significant difference in outcomes after 24 months.

Sclerotherapy was associated with fewer complications and lower treatment costs compared to the standard surgical approach, making it a safer and more efficient option for treating these cysts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is sclerotherapy with polidocanol a better treatment option for aneurysmal bone cyst compared to conventional curettage and bone grafting? Puthoor, D., Francis, L., Ismail, R.[2022]

In a study of 72 children with solitary bone cysts, both steroid injections and intramedullary nailing were effective treatments, achieving cure at an average of 4 years without significant differences in outcomes.

However, steroid injections were associated with more severe complications, including limb length discrepancies, particularly when higher doses were used, suggesting that intramedullary nailing may be the safer option for weight-bearing bones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of solitary bone cysts by intra-medullary nailing or steroid injection in children]. Journeau, P., Ciotlos, D.[2013]

In a study of 10 patients with benign bone tumors treated with injectable beta-tricalcium phosphate/calcium sulfate (GeneX), all patients showed complete radiographic healing and successfully resumed daily activities within a mean follow-up of 24 months.

The use of GeneX was found to be safe, with no complications or tumor recurrences reported, suggesting it is an effective alternative to traditional graft materials in managing bone defects after curettage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable Synthetic Beta-Tricalcium Phosphate/Calcium Sulfate (GeneX) for the Management of Contained Defects Following Curettage of Benign Bone Tumours. Razii, N., Docherty, LM., Halai, M., et al.[2023]

Intralesional injections of methylprednisolone for treating simple bone cysts resulted in a high success rate of 90% with only 5% recurrence, making it a highly effective treatment option.

Curettage alone had a lower success rate of 43% and a higher recurrence rate of 29%, but when combined with methylprednisolone injections, the outcomes were comparable to injections alone, suggesting that injections are a safer and simpler alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simple bone cysts. A review of 59 cases with special reference to their treatment. Mylle, J., Burssens, A., Fabry, G.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8889432/

Percutaneous Curettage and Local Autologous Cancellous ... The objective of this study was to evaluate the effectiveness and clinical outcome (local control and bone healing) of minimally invasive percutaneous curettage ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4647485/

Predictive characteristic of simple bone cyst treated with ... The aim of our study is to identify which type of cyst may be most effectively treated using curettage with grafting.

3. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2025.1633136/full

Effectiveness of curettage and bone grafting with and ... Conclusion: Curettage and bone grafting with elastic intramedullary nailing is superior to curettage and bone grafting alone for treating simple bone cysts, ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2019/06210/comparison_of_curettage_and_bone_grafting_combined.54.aspx

Comparison of curettage and bone grafting combined with... The results of this study show that EIN combined with curettage and bone grafting can significantly improve the effective rate of bone cyst treatment compared ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X23001637

Extended intralesional curettage with bone grafting for ... An extended intralesional curettage with autologous bone grafting is an excellent management option for ABC Talus, with hydrogen peroxide as an adjuvant.

6. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-020-02130-6

curettage and mixed bone grafting either with or without ... The primary aim of our study was to evaluate the comparative efficacy and safety profile of curettage and mixed bone grafting without instrument ...

7. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2025.1673245/full

Curettage and bone grafting combined with electrocautery ... The overall complication rate was 17.39%, including one case of infection, two cases of wound dehiscence, and one case of transient radial nerve palsy, all of ...

8. journals.healio.com journals.healio.com/doi/10.3928/01477447-20090201-13

Percutaneous Curettage and Bone Grafting for Humeral ... Radiographic evidence of cyst resolution occurred in 75% of our patients using percutaneous curettage and bone grafting, and in 95% of patients ...