ClinicalTrials.gg
Status unknownNCT01756144Updated May 28, 2015

rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport

An interventional study of rhBMP-2 in Pseudarthrosis, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-05-28.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

When there is a bone defect, bone transport is used to bridge the defect. Frequently, the bone in the docking site (where the transported bone comes together) doesn't heal.

The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in order to find new techniques to treat non-union of long bones.

The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous bone grafting in stimulating bone healing in the docking site.

02

Conditions studied

  • Pseudarthrosis

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03

In context

Pseudarthrosis

41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.

This study's planned enrollment of 20 is close to the median of 22 across 25 interventional studies indexed under Pseudarthrosis.

Browse Pseudarthrosis studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients treated with bone transport (Ilizarov technique) and have non-union of the docking site, which is characterized by absence of bridging callus after two months of compression in the docking site.

Exclusion criteria

Exclusion Criteria:

  • Allergy for inductos
  • active growth,
  • infection
  • PAD
  • pathological fracture
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Autologous bone grafting

    autologous bone of the iliac crest

    Device: rhBMP-2

  • Experimental
    rhBMP-2

    Inductos, recombinant human bone morphogenetic protein

    Device: rhBMP-2

Interventions

  • DevicerhBMP-2
06

What researchers measure

Primary outcomes

  1. Bone healing in the docking site

    Time frame: up to 4 months

Secondary outcomes

  1. Infection

    Time frame: up to one year

  2. Edema

    Time frame: up to one year

  3. cancer

    Time frame: up to one year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2015, a primary completion of Jan 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2012
First posted
Dec 25, 2012
Start
Jul 2015
Primary completionEst.
Jan 2016
CompletionEst.
Apr 2016
Last update
May 28, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01756144
Responsible party
Dr Jan Vanderstappen (MD, Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Dec 25, 2012
Start date
Jul 2015
Primary completion
Jan 2016 (estimated)
Completion
Apr 2016 (estimated)
Last update
May 28, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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