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Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04737590
Recruitment Status : Unknown
Verified February 2021 by Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
Bonalive Biomaterials Ltd
Information provided by (Responsible Party):
Turku University Hospital

Study Description
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Brief 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). The trial is carried out in five University Hospitals (Turku, Helsinki, Tampere, Oulu, Kuopio) in Finland.

Condition or disease Intervention/treatment Phase
Bone Cysts Device: Bioactive glass Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Curettage With Allogenic Bone Grafting and Curettage With Bioactive Glass Filling in Children With Bone Cysts CYSTS
Actual Study Start Date : September 5, 2012
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bioactive glass
20 bone cysts (in 20 patients) are filled with bioactive glass
 Device: Bioactive glass
Comparison of bioactive glass to allogenic bone in pediatric bone cysts
Active Comparator: Allogenic bone
20 bone cysts (in 20 patients) are filled with allogenic bone
 Device: Bioactive glass
Comparison of bioactive glass to allogenic bone in pediatric bone cysts


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: through study completion, average 2 years ]
    Cyst's recurrence

  2. Recurrence size [ Time Frame: through study completion, average 2 years ]
    The size of cyst recurrence

  3. Operation time [ Time Frame: during the surgery ]
    Time from the cut to the closure

  4. Blood loss [ Time Frame: during the surgery ]
    Operation's blood loss

  5. Complication [ Time Frame: during the surgery ]
    Complications at the operation

  6. Complication [ Time Frame: through study completion, average 2 years ]
    Complications during follow-up

  7. Hospital Stay [ Time Frame: immediately after the surgery ]
    Number of days spent at the hospital

  8. 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)

  9. 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)

  10. Fracture after operation [ Time Frame: through study completion, average 2 years ]
    Fracture after operation at the filled area in radiograph (yes / no)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Suspected aneurysmatic bone cyst in all areas, not spinal.
  2. Other large simple bone cyst in load bearing areas
  3. Simple or aneurysmal bone cyst and a pathological fracture in non load-bearing areas

Exclusion Criteria:

  1. Malignancy
  2. Bone marrow disease
  3. Other than aneurysmatic or simple bone cyst
  4. A secondary aneurysmal bone cyst (ABC associated with another underlying lesion)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737590


Contacts
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Contact: Johanna Syvänen, PhD +358 2 313 0000 johanna.syvanen@tyks.fi
Contact: Ilkka Helenius, Prof ilkka.helenius@tyks.fi

Locations
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Finland
Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Yrjänä Nietosvaara, PhD       yrjana.nietosvaara@hus.fi   
Kuopio University Hospital Recruiting
Kuopio, Finland
Contact: Jenni Jalkanen, Phd       jenni.jalkanen@kys.fi   
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Juha-Jaakko Sinikumpu, Prof       juha-jaakko.sinikumpu@ppshp.fi   
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Anne Salonen, PhD       anne.salonen@pshp.fi   
Turku University Hospital Recruiting
Turku, Finland
Contact: Johanna Syvänen, PhD    +358 2 313 0000    johanna.syvanen@tyks.fi   
Sponsors and Collaborators
Turku University Hospital
Bonalive Biomaterials Ltd
Investigators
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Study Director: Ilkka Helenius, Prof University of Helsinki
More Information
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT04737590    
Other Study ID Numbers: 123456
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cysts
Bone Cysts
Neoplasms
 Pathological Conditions, Anatomical
Bone Diseases
Musculoskeletal Diseases