Study Evaluating InductOs in Diaphyseal Tibia Fractures

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation

Conditions
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Tibial Fractures

Intervention / Treatment
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* Drug: InductOs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation | Drug: InductOs<br>* InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage<br>|
| Other: B<br>Standard of Care: Surgical fixation only | Drug: InductOs<br>* InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Healed Fractures | Patients categorized by investigator as healed, not healed, no outcome (using pre-specified criteria). Healed: no tenderness at fracture site or pain with weight bearing, presence of bridging callus or disappearance of fracture lines, no hardware failure, no secondary intervention to promote fracture healing. Not healed: diagnosis of delayed union or nonunion, hardware failure, secondary intervention procedure for fracture healing recommended or performed, or conduct of procedure that may interfere with fracture healing. No outcome: subjects who did not achieve either healed or not healed. | 13 and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE) | Patients categorized as Success or Failure of CCRE. Success defined as a fracture judged to be both clinically healed by clinical investigator, healed (see primary outcome), and radiographically united by independent, blinded radiology panel, united. Patients deemed not healed or not united were assessed as failures. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Diaphyseal Tibia Fractures