Bone CystsNCT04737590
Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts
A study testing Bioactive glass in people with Bone Cysts, run by Turku University Hospital at 5 sites in Finland.
Trial summary
The Finnish Paediatric Orthopedic Study Group will perform a prospective, randomized, multicenter, clinical trial comparing two bone substitutes (allograft and bioactive glass, BonAlive®) in treating bone cysts in children (18 years or younger). Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Cysts
- What is being tested?
- Bioactive glass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesFinland
- Study dates
- 5 Sep 2012to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Suspected aneurysmatic bone cyst in all areas, not spinal.
- Other large simple bone cyst in load bearing areas
- Simple or aneurysmal bone cyst and a pathological fracture in non load-bearing areas
Who cannot join
- Malignancy
- Bone marrow disease
- Other than aneurysmatic or simple bone cyst
- A secondary aneurysmal bone cyst (ABC associated with another underlying lesion)
Trial locations and contacts
5 sites in 1 country.
Ilkka Helenius, Prof contact
5 sites in 1 country
Finland5 sites, 5 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Yrjänä Nietosvaara, PhD, yrjana.nietosvaara@hus.fi
- Recruiting
Kuopio University Hospital
Kuopio
Jenni Jalkanen, Phd, jenni.jalkanen@kys.fi
- Recruiting
Oulu University Hospital
Oulu
Juha-Jaakko Sinikumpu, Prof, juha-jaakko.sinikumpu@ppshp.fi
- Recruiting
Tampere University Hospital
Tampere
Anne Salonen, PhD, anne.salonen@pshp.fi
- Recruiting
Turku University Hospital
Turku
Johanna Syvänen, PhD, +358 2 313 0000, johanna.syvanen@tyks.fi
About this study
Official title: A Randomized Clinical Trial Comparing Curettage With Allogenic Bone Grafting and Curettage With Bioactive Glass Filling in Children With Bone Cysts CYSTS
The Finnish Paediatric Orthopedic Study Group will perform a prospective, randomized, multicenter, clinical trial comparing two bone substitutes (allograft and bioactive glass, BonAlive®) in treating bone cysts in children (18 years or younger). The trial is carried out in five University Hospitals (Turku, Helsinki, Tampere, Oulu, Kuopio) in Finland.
Read the detailed description
Twenty patients will be randomized into each group. In all University Hospitals the treatment protocol will be same. Randomization will be performed using a sealed envelope technique.
Before surgery all patients will be examined clinically. After conventional radiographs all patients will be examined with magnetic resonance imaging showing cyst's size, anatomy, location and adjacent structures.
If the aneurysmal bone cyst is large or in difficult location, embolization by the radiologist can be used preoperatively.
Surgical technique:
Surgery will be done by experienced paediatric orthopaedic surgeons. Normal orthopaedic exposures will be used. The cyst is opened so that square window is done to the cortex. A sample to the pathologist is collected, also intraoperative frozen section is used to confirm the diagnosis. A mechanical curettage with use of a curette and a high speed burr is used to inspect the whole cavity. The tumour is resected as thoroughly as possible. After curettage 5% phenol is inserted to the cavity and it is neutralized with saline. Cyst volume is evaluated using saline (ml). Then the cyst is filled with morsellized femoral head allograft or bioactive glass (BG-S53P4) according to randomization. The biggest granule size 2-3,15mm is used for femur, tibia, pelvis and humerus. If the cyst volume is below 10ml in these places then smaller granule size (1-2mm) is chosen. If the cyst is in hand region then the granule size is 0,5-0,8mm. At the end of the operation the window's roof is inserted back. All the time X-ray is used to ensure that the whole cyst is treated properly. Osteosynthesis will be performed whenever it is necessary to prevent a pathological fracture.
After surgery the diagnosis will be confirmed histopathologically.
All patients will receive standard anesthesia.
Postoperatively an X-ray will be taken. Radiographic controls after surgery will be held at 1 Mo, 3 Mo, 6Mo, 12Mo and 24Mo. Three months control and two years control will be accompanied with MRI.
If the cyst is found after a pathologic fracture, the fracture is healed first with the cast +/- traction and MRI will be taken before surgery.
- Conditions
- Bone Cysts
- Being tested
- Bioactive glass
- Medical subject headings
- Bone Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive glassDevice
Comparison of bioactive glass to allogenic bone in pediatric bone cysts
| Study group | Role | What they receive |
|---|---|---|
| Bioactive glass | Active comparator | 20 bone cysts (in 20 patients) are filled with bioactive glass Receives: Device: Bioactive glass |
| Allogenic bone | Active comparator | 20 bone cysts (in 20 patients) are filled with allogenic bone Receives: Device: Bioactive glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Cyst's recurrence
Measured: through study completion, average 2 years
Recurrence size
The size of cyst recurrence
Measured: through study completion, average 2 years
Operation time
Time from the cut to the closure
Measured: during the surgery
Blood loss
Operation's blood loss
Measured: during the surgery
Complication
Complications at the operation
Measured: during the surgery
Complication
Complications during follow-up
Measured: through study completion, average 2 years
Hospital Stay
Number of days spent at the hospital
Measured: immediately after the surgery
Cyst-healing grade (Enneking's grading system)
Enneking's grading system (scale 1-3, 1=latent, 2=active, 3=aggressive)
Measured: through study completion, average 2 years
Function (Musculoskeletal society tumor score)
Musculoskeletal society tumor score (scale 0-5, 5=best outcome, 0=worst outcome)
Measured: through study completion, average 2 years
Fracture after operation
Fracture after operation at the filled area in radiograph (yes / no)
Measured: through study completion, average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start5 Sep 2012
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone CystsStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Bonalive Biomaterials Ltd
- Responsible party
- Sponsor
- Investigators
- Ilkka Helenius, Prof, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737590
- Sponsor's protocol ID
- 123456
- Status last verified
- Feb 2021
- First submitted
- 11 Dec 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Curettage With Allogenic Bone Grafting and Curettage With Bioactive Glass Filling in Children With Bone Cysts CYSTS
- ClinicalTrials.gov ID
- NCT04737590
- Acronym / sponsor ID
- 123456
- Conditions
- Bone Cysts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Bonalive Biomaterials Ltd
- Study start
- 5 Sep 2012 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Finnish Paediatric Orthopedic Study Group will perform a prospective, randomized, multicenter, clinical trial comparing two bone substitutes (allograft and bioactive glass, BonAlive®) in treating bone cysts in children (18 years or younger). The trial is carried out in five University Hospitals (Turku, Helsinki, Tampere, Oulu, Kuopio) in Finland.
Detailed description
Twenty patients will be randomized into each group. In all University Hospitals the treatment protocol will be same. Randomization will be performed using a sealed envelope technique.
Before surgery all patients will be examined clinically. After conventional radiographs all patients will be examined with magnetic resonance imaging showing cyst's size, anatomy, location and adjacent structures.
If the aneurysmal bone cyst is large or in difficult location, embolization by the radiologist can be used preoperatively.
Surgical technique:
Surgery will be done by experienced paediatric orthopaedic surgeons. Normal orthopaedic exposures will be used. The cyst is opened so that square window is done to the cortex. A sample to the pathologist is collected, also intraoperative frozen section is used to confirm the diagnosis. A mechanical curettage with use of a curette and a high speed burr is used to inspect the whole cavity. The tumour is resected as thoroughly as possible. After curettage 5% phenol is inserted to the cavity and it is neutralized with saline. Cyst volume is evaluated using saline (ml). Then the cyst is filled with morsellized femoral head allograft or bioactive glass (BG-S53P4) according to randomization. The biggest granule size 2-3,15mm is used for femur, tibia, pelvis and humerus. If the cyst volume is below 10ml in these places then smaller granule size (1-2mm) is chosen. If the cyst is in hand region then the granule size is 0,5-0,8mm. At the end of the operation the window's roof is inserted back. All the time X-ray is used to ensure that the whole cyst is treated properly. Osteosynthesis will be performed whenever it is necessary to prevent a pathological fracture.
After surgery the diagnosis will be confirmed histopathologically.
All patients will receive standard anesthesia.
Postoperatively an X-ray will be taken. Radiographic controls after surgery will be held at 1 Mo, 3 Mo, 6Mo, 12Mo and 24Mo. Three months control and two years control will be accompanied with MRI.
If the cyst is found after a pathologic fracture, the fracture is healed first with the cast +/- traction and MRI will be taken before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioactive glass | Active comparator | Device: Bioactive glass20 bone cysts (in 20 patients) are filled with bioactive glass |
| Allogenic bone | Active comparator | Device: Bioactive glass20 bone cysts (in 20 patients) are filled with allogenic bone |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Suspected aneurysmatic bone cyst in all areas, not spinal.
- Other large simple bone cyst in load bearing areas
- Simple or aneurysmal bone cyst and a pathological fracture in non load-bearing areas
Key exclusion criteria (4 listed)
- Malignancy
- Bone marrow disease
- Other than aneurysmatic or simple bone cyst
- A secondary aneurysmal bone cyst (ABC associated with another underlying lesion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioactive glassComparison of bioactive glass to allogenic bone in pediatric bone cysts | Device | Allogenic bone, Bioactive glass |
Primary outcome
Recurrence rate
Time frame: through study completion, average 2 years
Cyst's recurrence
Recurrence size
Time frame: through study completion, average 2 years
The size of cyst recurrence
Operation time
Time frame: during the surgery
Time from the cut to the closure
Blood loss
Time frame: during the surgery
Operation's blood loss
Complication
Time frame: during the surgery
Complications at the operation
Complication
Time frame: through study completion, average 2 years
Complications during follow-up
Hospital Stay
Time frame: immediately after the surgery
Number of days spent at the hospital
Cyst-healing grade (Enneking's grading system)
Time frame: through study completion, average 2 years
Enneking's grading system (scale 1-3, 1=latent, 2=active, 3=aggressive)
Function (Musculoskeletal society tumor score)
Time frame: through study completion, average 2 years
Musculoskeletal society tumor score (scale 0-5, 5=best outcome, 0=worst outcome)
Fracture after operation
Time frame: through study completion, average 2 years
Fracture after operation at the filled area in radiograph (yes / no)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilkka Helenius, Prof contact
Ilkka Helenius, Prof study director
University of Helsinki
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive glass in people with Bone Cysts, run by Turku University Hospital at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Syvänen, PhD (+358 2 313 0000, johanna.syvanen@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: through study completion, average 2 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.