Study Evaluating InductOs in Diaphyseal Tibia Fractures

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

InductOs

About this trial

This is an interventional treatment trial for Tibial Fractures focused on measuring Open Diaphyseal Tibia Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

A

B

Arm Description

InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation

Standard of Care: Surgical fixation only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00161616

First Posted

September 7, 2005

Last Updated

July 31, 2009

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00161616

Brief Title

Study Evaluating InductOs in Diaphyseal Tibia Fractures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tibial Fractures

Keywords

Open Diaphyseal Tibia Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

277 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Active Comparator

Arm Description

InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation

Arm Title

B

Arm Type

Other

Arm Description

Standard of Care: Surgical fixation only

Intervention Type

Drug

Intervention Name(s)

InductOs

Intervention Description

InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage

Primary Outcome Measure Information:

Title

Number of Patients With Healed Fractures

Description

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.

Time Frame

13 and 20 weeks

Secondary Outcome Measure Information:

Title

Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)

Description

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.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials: