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Study Evaluating InductOs in Diaphyseal Tibia Fractures

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NCT00161616

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Gent, , 9000 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tibial Fractures
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with acute open tibial shaft fractures (Gustilo Type I, II, IIIA, or IIIB)
who require surgical management with reamed, statically locked intramedullary nail
fixation and who are at low risk for amputation.

- Subjects should be at least 18 years of age, be skeletally mature, and be able to
provide written informed consent.

- Initial fracture stabilization and wound debridement should occur within 1 day after
injury and DFC should occur within 14 days after injury.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Planned treatment for the fracture should not include further procedures to promote
fracture healing. After 16 weeks have elapsed since DFC, unanticipated procedures to
promote fracture healing are permitted as clinically indicated.

- Presence of fracture distraction > 2 mm following definitive fracture fixation.

- Presence of purulent drainage from the fracture site or evidence of active
osteomyelitis.

NCT00161616
Pfizer
Completed
Study Evaluating InductOs in Diaphyseal Tibia Fractures

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Study Evaluating InductOs in Diaphyseal Tibia Fractures
A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation
Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Tibial Fractures
Drug: InductOs
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
  • Active Comparator: A
    InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation
    Intervention: Drug: InductOs
  • B
    Standard of Care: Surgical fixation only
    Intervention: Drug: InductOs
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
277
August 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with acute open tibial shaft fractures (Gustilo Type I, II, IIIA, or IIIB) who require surgical management with reamed, statically locked intramedullary nail fixation and who are at low risk for amputation.
  • Subjects should be at least 18 years of age, be skeletally mature, and be able to provide written informed consent.
  • Initial fracture stabilization and wound debridement should occur within 1 day after injury and DFC should occur within 14 days after injury.

Exclusion Criteria:

  • Planned treatment for the fracture should not include further procedures to promote fracture healing. After 16 weeks have elapsed since DFC, unanticipated procedures to promote fracture healing are permitted as clinically indicated.
  • Presence of fracture distraction > 2 mm following definitive fracture fixation.
  • Presence of purulent drainage from the fracture site or evidence of active osteomyelitis.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Finland,   France,   Germany,   Italy,   Netherlands,   Norway,   Poland,   Romania,   South Africa,   Spain,   United Kingdom
 
 
NCT00161616
3100N8-400
No
Not Provided
Not Provided
Wyeth (Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Italy, [email protected]
Principal Investigator: Trial Manager For South Africa, [email protected]
Principal Investigator: Trial Manager For Norway, Finland, [email protected]
Principal Investigator: Trial Manager For Spain, [email protected]
Study Chair: Trial Manager For UK/Great Britian, [email protected]
Principal Investigator: Trial Manager For Belgium, [email protected]
Principal Investigator: Trial Manager For France, [email protected]
Principal Investigator: Trial Manager For Romania, [email protected]
Principal Investigator: Trial Manager For Netherlands, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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