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

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. ^{1 2 3 4 5}

Is 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. ^{2 3 4 6 7}

How 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. ^{1 8 9 10 11}

Research Team

Sevan Hopyan

Principal Investigator

The Hospital for Sick Children

James G. Wright

Principal Investigator

The Hospital for Sick Children

Eligibility 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)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment of simple bone cysts using endoscopic curettage: a case series analysis. [2022]

2. United States 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. [2022]

3. United States 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. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Simple bone cysts. A review of 59 cases with special reference to their treatment. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Curettage of benign bone tumors and tumor like lesions: A retrospective analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Use of purified beta-tricalcium phosphate for filling defects after curettage of benign bone tumours. [2022]

7. Switzerland 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. [2023]

8. England 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. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Is sclerotherapy with polidocanol a better treatment option for aneurysmal bone cyst compared to conventional curettage and bone grafting? [2022]

10. Uganda pubmed.ncbi.nlm.nih.gov

Unicameral (simple) and aneurysmal bone cysts: the effect of insufficient curettage on recurrence. [2018]

11. France pubmed.ncbi.nlm.nih.gov

[Treatment of solitary bone cysts by intra-medullary nailing or steroid injection in children]. [2013]