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.

Study Overview

• Status: Completed
• Conditions: Tibial Fractures
• Intervention / Treatment: Drug: InductOs

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
• Finland
  • Turku, Finland, 20520
• France
  • Creteil, France, 94010
  • Toulouse, France, 31400
• Germany
  • Berlin, Germany, 13353
  • Mainz, Germany, 55131
  • Muenster, Germany, 48149
• Italy
  • Pavia, Italy, 27100
  • Roma, Italy, 00168
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
• Norway
  • Bergen, Norway, 5021
  • Oslo, Norway, 0407
• Poland
  • Bialystok, Poland, 15276
  • Lublin, Poland, 20954
  • Sosnowiec, Poland, 41200
  • Szczecin, Poland, 71252
• Romania
  • Bucuresti, Romania, 14461
  • Bucuresti, Romania, 21659
  • Bucuresti, Romania, 50098
• South Africa
  • Bloemfontein, South Africa, 9300
  • Cape Town, South Africa, 7925
  • Cape Town, South Africa, 7505
  • Centurion, South Africa, 0157
  • Durban, South Africa
• Spain
  • Alcala, Spain, 28805
• United Kingdom
  • Bristol, United Kingdom, BS2 8HW
  • Norwich, United Kingdom, NR4 7 UY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For Romania, WVPIMED@wyeth.com; Principal Investigator: Trial Manager, For Spain, infomed@wyeth.com; Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com; Principal Investigator: Trial Manager, For Norway, Finland, MedInfoNord@wyeth.com; Study Chair: Trial Manager, For UK/Great Britian, ukmedinfo@wyeth.com

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): September 7, 2009
• Last Update Submitted That Met QC Criteria: July 31, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Open Diaphyseal Tibia Fractures
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: 3100N8-400