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

Primary Purpose

Non-union Diaphysary Tibial Fractures

Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
BMP-7 in adjunct to fresh frozen allograft
allograft together with DBM
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-union Diaphysary Tibial Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ Sint Jan-Brugge
  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

non-union of diaphysary tibial fractures will be treated with allograft together with DBM

non-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft

Outcomes

Primary Outcome Measures

X-ray evaluation
Change in VAS and LEFS scores

Secondary Outcome Measures

Time of incapacity to work
Change in SF-36
Total socio-economic cost estimation
Repeated surgery (minor and major)
(Surgical) complications
Ability to bear weight (% of body weight)

Full Information

First Posted
October 30, 2007
Last Updated
July 7, 2021
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00551941
Brief Title
A Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and Demineralized Bone Matrix in Tibial Non-union
Official Title
A Prospective Randomised Controlled Trial on the Use of BMP-7 (OP-1®) and Demineralised Bone Matrix in Tibial Non-union
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment problems
Study Start Date
October 2007 (Actual)
Primary Completion Date
July 9, 2012 (Actual)
Study Completion Date
July 9, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-union Diaphysary Tibial Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
non-union of diaphysary tibial fractures will be treated with allograft together with DBM
Arm Title
1
Arm Type
Experimental
Arm Description
non-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft
Intervention Type
Procedure
Intervention Name(s)
BMP-7 in adjunct to fresh frozen allograft
Intervention Description
non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft
Intervention Type
Procedure
Intervention Name(s)
allograft together with DBM
Intervention Description
non-union of diaphysary tibial fractures treated with allograft together with DBM
Primary Outcome Measure Information:
Title
X-ray evaluation
Time Frame
After 9 months
Title
Change in VAS and LEFS scores
Time Frame
After 9 months
Secondary Outcome Measure Information:
Title
Time of incapacity to work
Time Frame
Until ability to work
Title
Change in SF-36
Time Frame
After 4 years
Title
Total socio-economic cost estimation
Time Frame
After 4 years
Title
Repeated surgery (minor and major)
Time Frame
After 4 years
Title
(Surgical) complications
Time Frame
After 4 years
Title
Ability to bear weight (% of body weight)
Time Frame
After 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rene Verdonk, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint Jan-Brugge
City
Brugge
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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