A Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and Demineralized Bone Matrix in Tibial Non-union

July 7, 2021 updated by: University Hospital, Ghent

A Prospective Randomised Controlled Trial on the Use of BMP-7 (OP-1®) and Demineralised Bone Matrix in Tibial Non-union

The researchers propose a prospective, randomised partially-blinded study to investigate the clinical and radiological outcome, effect on quality of life and socio-economic impact of non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft, in comparison to treatment with allograft together with DBM (demineralised bone matrix).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Belgium
      • Brugge, Belgium
        • AZ Sint Jan-Brugge
      • Ghent, Belgium, 9000
        • University Hospital Ghent

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diaphysary tibial non-unions will be included (9 months after first surgery)
  • Major surgery includes exchange nailing, bone grafting, internal fixation, amputation and soft-tissue coverage procedures, such as delayed primary closure and free flaps
  • Surgery is classified as minor for removal of external fixator pins for local infection and removal of a static locking screw from intramedullary nails, a procedure known as dynamization
  • ASA 1 and ASA 2
  • Gap length/bone contact detected (1-5 cm): largest cortical gap in any radiographic incidence
  • Subject or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent, which has been approved by the Institutional Review Board
  • Agrees to participate in post-operative evaluations and required rehabilitation regimen

Exclusion Criteria:

  • Patients with known hypersensitivity to the active substance or collagen
  • Gap more than 5 cm
  • Immature skeleton
  • Known auto-immune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis
  • Active infection on unhealed site or active systemic infection
  • Non-healing resulting from pathological fractures, tumours or metabolic bone diseases
  • Presence of tumour in vicinity of non-union
  • Patients receiving chemotherapy, radiotherapy or immunosuppressant treatment or excessive steroids
  • Patients with severely compromised soft tissue coverage or vascularisation at the non-union site, sufficient to impair bone healing
  • Patients with congenital non-union
  • Pregnancy and lactation
  • Non-union of multiple bones interfering with walking
  • Patients with neuromuscular diseases or conditions interfering normal weight bearing
  • Patients who, judged by the surgeon, are candidates for just internal fixation alone

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
non-union of diaphysary tibial fractures will be treated with allograft together with DBM
Procedure: allograft together with DBM
non-union of diaphysary tibial fractures treated with allograft together with DBM
EXPERIMENTAL: 1
non-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft
Procedure: BMP-7 in adjunct to fresh frozen allograft
non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
X-ray evaluation
Time Frame: After 9 months
After 9 months
Change in VAS and LEFS scores
Time Frame: After 9 months
After 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of incapacity to work
Time Frame: Until ability to work
Until ability to work
Change in SF-36
Time Frame: After 4 years
After 4 years
Total socio-economic cost estimation
Time Frame: After 4 years
After 4 years
Repeated surgery (minor and major)
Time Frame: After 4 years
After 4 years
(Surgical) complications
Time Frame: After 4 years
After 4 years
Ability to bear weight (% of body weight)
Time Frame: After 4 years
After 4 years

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

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)

October 1, 2007

Primary Completion (ACTUAL)

July 9, 2012

Study Completion (ACTUAL)

July 9, 2012

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 31, 2007

First Posted (ESTIMATE)

November 1, 2007

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/341

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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