Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts

Bone Cysts Clinical Trial

Official title:

A Randomized Clinical Trial Comparing Curettage With Allogenic Bone Grafting and Curettage With Bioactive Glass Filling in Children With Bone Cysts CYSTS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737590
• Other study ID #: 123456
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2012
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2021
• Source: Turku University Hospital
• Contact: Johanna Syvänen, PhD
• Phone: +358 2 313 0000
• Email: johanna.syvanen[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bone Cysts
• Cysts

Intervention

Device:
• Bioactive glass
Comparison of bioactive glass to allogenic bone in pediatric bone cysts

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Oulu University Hospital	Oulu
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Bonalive Biomaterials Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	Cyst's recurrence	through study completion, average 2 years
Primary	Recurrence size	The size of cyst recurrence	through study completion, average 2 years
Primary	Operation time	Time from the cut to the closure	during the surgery
Primary	Blood loss	Operation's blood loss	during the surgery
Primary	Complication	Complications at the operation	during the surgery
Primary	Complication	Complications during follow-up	through study completion, average 2 years
Primary	Hospital Stay	Number of days spent at the hospital	immediately after the surgery
Primary	Cyst-healing grade (Enneking's grading system)	Enneking's grading system (scale 1-3, 1=latent, 2=active, 3=aggressive)	through study completion, average 2 years
Primary	Function (Musculoskeletal society tumor score)	Musculoskeletal society tumor score (scale 0-5, 5=best outcome, 0=worst outcome)	through study completion, average 2 years
Primary	Fracture after operation	Fracture after operation at the filled area in radiograph (yes / no)	through study completion, average 2 years