Study Evaluating InductOs in Diaphyseal Tibia Fractures

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NCT00161616

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Study Location
Gent, , 9000, Belgium
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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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.

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Tibial FracturesStudy Evaluating InductOs in Diaphyseal Tibia Fractures
NCT00161616
  1. Gent,
  2. Turku,
  3. Creteil,
  4. Toulouse,
  5. Berlin,
  6. Mainz,
  7. Muenster,
  8. Pavia,
  9. Roma,
  10. Rotterdam,
  11. Bergen,
  12. Oslo,
  13. Bialystok,
  14. Lublin,
  15. Sosnowiec,
  16. Szczecin,
  17. Bucuresti,
  18. Bucuresti,
  19. Bucuresti,
  20. Bloemfontein,
  21. Cape Town,
  22. Cape Town,
  23. Centurion,
  24. Durban,
  25. Alcala,
  26. Bristol,
  27. Norwich,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating InductOs in Diaphyseal Tibia Fractures
Official Title  ICMJE A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tibial Fractures
Intervention  ICMJE Drug: InductOs
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2009)		277
Original Enrollment  ICMJE
 (submitted: September 7, 2005)		300
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Finland,   France,   Germany,   Italy,   Netherlands,   Norway,   Poland,   Romania,   South Africa,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161616
Other Study ID Numbers  ICMJE 3100N8-400
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor South Africa, [email protected]
Principal Investigator:Trial ManagerFor Norway, Finland, [email protected]
Principal Investigator:Trial ManagerFor Spain, [email protected]
Study Chair:Trial ManagerFor UK/Great Britian, [email protected]
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor Romania, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

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