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

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00551941

Purpose

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).

Condition	Intervention	Phase
Non-Union Diaphysary Tibial Fractures	Procedure: BMP-7 in adjunct to fresh frozen allograft Procedure: allograft together with DBM	Phase IV

MedlinePlus related topics: Fractures

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective Randomised Controlled Trial on the Use of BMP-7 (OP-1®) and Demineralised Bone Matrix in Tibial Non-Union

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator 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
1: Experimental 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diaphysary tibial non-unions will be included (9 months after last major 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551941

Contacts

Contact: Stefan Desmyter, MD

stefandesmyter@yahoo.com

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Stefan Desmyter, MD stefandesmyter@yahoo.com
Principal Investigator: Stefan Desmyter, MD
AZ Sint Jan-Brugge	Recruiting
Brugge, Belgium
Contact: De Groote, MD
Principal Investigator: De Groote, MD

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Rene Verdonk, MD, PhD

University Hospital, Ghent

More Information

Responsible Party:	University Hospital Ghent ( René Verdonk, MD, PhD )
Study ID Numbers:	2007/341
Study First Received:	October 30, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00551941
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries
Tibial Fractures

ClinicalTrials.gov processed this record on January 15, 2009