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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. 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
Bonalive Biomaterials Ltd
Information provided by (Responsible Party):
Turku University Hospital

Tracking Information
First Submitted Date  ICMJE December 11, 2020
First Posted Date  ICMJE February 4, 2021
Last Update Posted Date February 4, 2021
Actual Study Start Date  ICMJE September 5, 2012
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2021)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts
Official Title  ICMJE A Randomized Clinical Trial Comparing Curettage With Allogenic Bone Grafting and Curettage With Bioactive Glass Filling in Children With Bone Cysts CYSTS
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bone Cysts
Intervention  ICMJE Device: Bioactive glass
Comparison of bioactive glass to allogenic bone in pediatric bone cysts
Study Arms  ICMJE
  • Active Comparator: Bioactive glass
    20 bone cysts (in 20 patients) are filled with bioactive glass
    Intervention: Device: Bioactive glass
  • Active Comparator: Allogenic bone
    20 bone cysts (in 20 patients) are filled with allogenic bone
    Intervention: Device: Bioactive glass
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 1, 2021)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04737590
Other Study ID Numbers  ICMJE 123456
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Turku University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Turku University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bonalive Biomaterials Ltd
Investigators  ICMJE
Study Director: Ilkka Helenius, Prof University of Helsinki
PRS Account Turku University Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP