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Adjunctive Therapy to Treat Tibial Shaft Fractures (TSF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00533793
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : March 16, 2012
Sponsor:
Collaborator:
Baxter BioScience
Information provided by (Responsible Party):
Kuros Biosurgery AG

Study Description
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Brief Summary:
A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.

Condition or disease Intervention/treatment Phase
Trauma Procedure: open fracture reduction Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures
Study Start Date : April 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: SoC
Standard of Care
 Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
Active Comparator: SoC plus 0.133 mg/mL Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
Active Comparator: SoC plus 0.4 mg/mL Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
Active Comparator: SoC plus 1.0 mg/mL Procedure: open fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Criteria:weight bearing,red.pain,walking without aid;lack of need for surg. interv. fracture site;Radiogr. crit.:Cortical bridging,disintegration/disappearance fracture lines,absence of signs for complications(infection,malunion) [ Time Frame: short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year) ]

Secondary Outcome Measures :
  1. Prop. patients healed 3,9,12 mths after T0; prop. time, extent radiogr. union for 2,3,4,5,6,9,12 mths after T0; Eval.:6 and 12 mths; prop./invasiven. sec. interv. due to persistent non-union within 6,12 mths after T0. [ Time Frame: short term follow-up: 6 months; long term follow-up: additional 6 months (1 year) ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible patients must meet all of the following inclusion criteria:

  1. patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and current radiographs indicated for open fracture reduction and internal fixation using osteosynthesis plates or intra-medullary nails
  2. soft tissue management (if medically warranted, eg. debridement, irrigation, application of antibiotics) performed according to local hospital practice no later than 24h after the trauma
  3. male and female patients >= 18 years
  4. body mass index (BMI) 16-33 (minimum body weight 50 kg, maximum 140 kg)
  5. females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening)

  6. females of child-bearing potential randomized in the intervention group must agree to have acceptable contraception for at least 3 months after receiving the study medication.

    Acceptable contraceptive measures are:

    • Hormonal types of birth control with a failure rate of less than 1% per year (such as implants, injections, combined oral contraceptives, patches or other methods) or copper IUDs or other IUDs with a failure rate of less than 1% per year, AND
    • An additional barrier type of birth control measure (such as condoms, diaphragms, cervical caps, etc.) Sterilized women and abstinent women of child-bearing potential will not be required to take contraceptive measures
  7. willingness and ability to understand, participate and comply with the study requirements
  8. patient be able to give consent personally and sign the Informed Consent Form.

Exclusion criteria:

Patients will be not eligible if they meet one of the following exclusion criteria:

  1. IIIc open fracture according to the Gustilo-Anderson classification
  2. tibial defects requiring bone-grafting (e.g. large segmental defects)
  3. duration from trauma to surgery longer than 14 days
  4. concomitant acute bone injuries and/or major skin or other significant injuries that in the opinion of the investigator would interfere with the tibial shaft fracture healing process
  5. concomitant ipsilateral tibial fractures other than in the diaphyseal region
  6. evidence of immune suppression
  7. suspected or known hypersensitivity to the study medication or components of it
  8. evidence of hypercalcemia
  9. hyperparathyroidism
  10. on treatment and/or planned treatment with products containing PTH (e.g. Forteo)
  11. pregnant or lactating females
  12. participation in another clinical trial within the last 3 months
  13. active or past history of malignant tumor
  14. history or evidence for any hereditary or acquired chronic metabolic bone disease other than primary osteoporosis.
  15. history or evidence for any clinically relevant organ failure or any other relevant medical condition that, in the opinion of the investigator, will relevantly interfere with the assessment of study outcome or will impose hazard to the patient if study therapy will be initiated
  16. known history of allergy to anaesthetics
  17. evidence of moderate or severe renal failure (serum creatinine > 3.0 times ULN, NCI CTC grades 3 and 4)
  18. known history of allergic thrombocytopenia (type II) induced by heparin
  19. inexplicable elevations of alkaline phosphatase or alkaline phosphatase > 5.0 times ULN, NCI CTC grades 3 and 4
  20. prior external beam or implant radiation therapy to the skeleton
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533793


Locations
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Sponsors and Collaborators
Kuros Biosurgery AG
Baxter BioScience
Investigators
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Study Director: Virginia Jamieson, MD Kuros Biosurgery
More Information
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Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT00533793    
Other Study ID Numbers: CS I-040202/01
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012
Keywords provided by Kuros Biosurgery AG:
bone, tibial shaft fracture
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries