Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts

February 1, 2021 updated by: Turku University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: through study completion, average 2 years
Cyst's recurrence
through study completion, average 2 years
Recurrence size
Time Frame: through study completion, average 2 years
The size of cyst recurrence
through study completion, average 2 years
Operation time
Time Frame: during the surgery
Time from the cut to the closure
during the surgery
Blood loss
Time Frame: during the surgery
Operation's blood loss
during the surgery
Complication
Time Frame: during the surgery
Complications at the operation
during the surgery
Complication
Time Frame: through study completion, average 2 years
Complications during follow-up
through study completion, average 2 years
Hospital Stay
Time Frame: immediately after the surgery
Number of days spent at the hospital
immediately after the surgery
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)
through study completion, average 2 years
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)
through study completion, average 2 years
Fracture after operation
Time Frame: through study completion, average 2 years
Fracture after operation at the filled area in radiograph (yes / no)
through study completion, average 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

Bonalive Biomaterials Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2012

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 11, 2020

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123456 (UMMashhad)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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