Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts

Not Applicable

• Conditions: Bone Cysts
• Interventions: Device: Bioactive glass

• Registration Number: NCT04737590
• Lead Sponsor: Turku University Hospital

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 Timeline

• Study Start: 2012-09-05
• Study First Submitted: 2020-12-11
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-01
• Last Update Submitted: 2021-02-01
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioactive glass	Bioactive glass	20 bone cysts (in 20 patients) are filled with bioactive glass
Allogenic bone	Bioactive glass	20 bone cysts (in 20 patients) are filled with allogenic bone

Primary Outcome Measures

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

Trial Locations

Locations (5)

Oulu University Hospital; 🇫🇮 Oulu, Finland

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland