NCT04737590

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2012

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

10.3 years

First QC Date

December 11, 2020

Last Update Submit

February 1, 2021

Conditions

Bone Cysts

Outcome Measures

Primary Outcomes (10)

  • Recurrence rate

    Cyst's recurrence

    through study completion, average 2 years

  • Recurrence size

    The size of cyst recurrence

    through study completion, average 2 years

  • Operation time

    Time from the cut to the closure

    during the surgery

  • Blood loss

    Operation's blood loss

    during the surgery

  • Complication

    Complications at the operation

    during the surgery

  • Complication

    Complications during follow-up

    through study completion, average 2 years

  • Hospital Stay

    Number of days spent at the hospital

    immediately after the surgery

  • 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

  • Function (Musculoskeletal society tumor score)

    Musculoskeletal society tumor score (scale 0-5, 5=best outcome, 0=worst outcome)

    through study completion, average 2 years

  • Fracture after operation

    Fracture after operation at the filled area in radiograph (yes / no)

    through study completion, average 2 years

Study Arms (2)

Bioactive glass

ACTIVE COMPARATOR

20 bone cysts (in 20 patients) are filled with bioactive glass

Device: Bioactive glass

Allogenic bone

ACTIVE COMPARATOR

20 bone cysts (in 20 patients) are filled with allogenic bone

Device: Bioactive glass

Interventions

Bioactive glassDEVICE

Comparison of bioactive glass to allogenic bone in pediatric bone cysts

Allogenic boneBioactive glass

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Suspected aneurysmatic bone cyst in all areas, not spinal.
  • Other large simple bone cyst in load bearing areas
  • Simple or aneurysmal bone cyst and a pathological fracture in non load-bearing areas

You may not qualify if:

  • Malignancy
  • Bone marrow disease
  • Other than aneurysmatic or simple bone cyst
  • A secondary aneurysmal bone cyst (ABC associated with another underlying lesion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

RECRUITING

Oulu University Hospital

Oulu, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Bone Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Ilkka Helenius, Prof

    University of Helsinki

    STUDY DIRECTOR

Central Study Contacts

Johanna Syvänen, PhD

CONTACT

+358 2 313 0000johanna.syvanen@tyks.fi

Ilkka Helenius, Prof

CONTACT

ilkka.helenius@tyks.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

February 4, 2021

Study Start

September 5, 2012

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

FI(5)