Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts

• ClinicalTrials.gov Identifier: NCT04737590
• Recruitment Status: Unknown
• First Posted: February 4, 2021
• Last Update Posted: February 4, 2021
• Sponsor: Turku University Hospital
• Collaborator: Bonalive Biomaterials Ltd
• Information provided by (Responsible Party): Turku University Hospital

Tracking Information

• First Submitted Date: December 11, 2020
• First Posted Date: February 4, 2021
• Last Update Posted Date: February 4, 2021
• Actual Study Start Date: September 5, 2012
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Bone Cysts

Intervention

Device: Bioactive glass

Comparison of bioactive glass to allogenic bone in pediatric bone cysts

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 1, 2021): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT04737590
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Turku University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Turku University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Bonalive Biomaterials Ltd

Investigators

• Study Director: Ilkka Helenius, Prof; University of Helsinki

• PRS Account: Turku University Hospital
• Verification Date: February 2021