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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

This study has suspended participant recruitment.
(Recruitment problems)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00551941
First received: October 30, 2007
Last updated: July 10, 2012
Last verified: July 2012
History of Changes

October 30, 2007
July 10, 2012
October 2007
July 2012   (final data collection date for primary outcome measure)
  • X-ray evaluation [ Time Frame: After 9 months ] [ Designated as safety issue: No ]
  • Change in VAS and LEFS scores [ Time Frame: After 9 months ] [ Designated as safety issue: Yes ]
  • X-ray evaluation [ Time Frame: After 9 months ]
  • Change in VAS and LEFS scores [ Time Frame: After 9 months ]
Complete list of historical versions of study NCT00551941 on ClinicalTrials.gov Archive Site
  • Time of incapacity to work [ Time Frame: Until ability to work ] [ Designated as safety issue: No ]
  • Change in SF-36 [ Time Frame: After 4 years ] [ Designated as safety issue: No ]
  • Total socio-economic cost estimation [ Time Frame: After 4 years ] [ Designated as safety issue: No ]
  • Repeated surgery (minor and major) [ Time Frame: After 4 years ] [ Designated as safety issue: Yes ]
  • (Surgical) complications [ Time Frame: After 4 years ] [ Designated as safety issue: Yes ]
  • Ability to bear weight (% of body weight) [ Time Frame: After 4 years ] [ Designated as safety issue: No ]
  • Time of incapacity to work [ Time Frame: Until ability to work ]
  • Change in SF-36 [ Time Frame: Within x time ]
  • Total socio-economic cost estimation [ Time Frame: Within x time ]
  • Repeated surgery (minor and major) [ Time Frame: Within x time ]
  • (Surgical) complications [ Time Frame: Within x time ]
  • Ability to bear weight (% of body weight) [ Time Frame: Within x time ]
Not Provided
Not Provided
 
A Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and Demineralized Bone Matrix in Tibial Non-union
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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Non-union Diaphysary Tibial Fractures
  • 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
  • Procedure: allograft together with DBM
    non-union of diaphysary tibial fractures treated with allograft together with DBM
  • Active Comparator: 2
    non-union of diaphysary tibial fractures will be treated with allograft together with DBM
    Intervention: Procedure: allograft together with DBM
  • Experimental: 1
    non-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft
    Intervention: Procedure: BMP-7 in adjunct to fresh frozen allograft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
30
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00551941
2007/341
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Rene Verdonk, MD, PhD University Hospital, Ghent
University Hospital, Ghent
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP