NCT00161616

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_4

Geographic Reach
12 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 7, 2009

Completed
Last Updated

September 7, 2009

Status Verified

July 1, 2009

Enrollment Period

4.8 years

First QC Date

September 7, 2005

Results QC Date

July 31, 2009

Last Update Submit

July 31, 2009

Conditions

Tibial Fractures

Keywords

Open Diaphyseal Tibia Fractures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    1 year

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: InductOs

B

OTHER

Standard of Care: Surgical fixation only

Drug: InductOs

Interventions

InductOsDRUG

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

AB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

Turku, 20520, Finland

Location

Unknown Facility

Créteil, 94010, France

Location

Unknown Facility

Toulouse, 31400, France

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Mainz, 55131, Germany

Location

Unknown Facility

Münster, 48149, Germany

Location

Unknown Facility

Pavia, 27100, Italy

Location

Unknown Facility

Roma, 00168, Italy

Location

Unknown Facility

Rotterdam, 3015 GD, Netherlands

Location

Unknown Facility

Bergen, 5021, Norway

Location

Unknown Facility

Oslo, 0407, Norway

Location

Unknown Facility

Bialystok, 15276, Poland

Location

Unknown Facility

Lublin, 20954, Poland

Location

Unknown Facility

Sosnowiec, 41200, Poland

Location

Unknown Facility

Szczecin, 71252, Poland

Location

Unknown Facility

Bucharest, 14461, Romania

Location

Unknown Facility

Bucharest, 21659, Romania

Location

Unknown Facility

Bucharest, 50098, Romania

Location

Unknown Facility

Bloemfontein, 9300, South Africa

Location

Unknown Facility

Cape Town, 7505, South Africa

Location

Unknown Facility

Cape Town, 7925, South Africa

Location

Unknown Facility

Centurion, 0157, South Africa

Location

Unknown Facility

Durban, South Africa

Location

Unknown Facility

Alcalá, 28805, Spain

Location

Unknown Facility

Bristol, BS2 8HW, United Kingdom

Location

Unknown Facility

Norwich, NR4 7 UY, United Kingdom

Location

MeSH Terms

Conditions

Tibial Fractures

Interventions

Bone Morphogenetic Protein 2

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Bone Morphogenetic ProteinsTGF-beta Superfamily ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
U. S. Contact Center
Organization
Wyeth
clintrialresults@wyeth.com

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Germany, MedInfoDEU@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Italy, descresg@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For South Africa, ZAFinfo@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Norway, Finland, MedInfoNord@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Spain, infomed@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For UK/Great Britian, ukmedinfo@wyeth.com

    STUDY CHAIR

  • Trial Manager

    For Belgium, trials-BEL@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For France, infomedfrance@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Romania, WVPIMED@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Netherlands, trials-NL@wyeth.com

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

September 1, 2003

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

September 7, 2009

Results First Posted

September 7, 2009

Record last verified: 2009-07

Locations

NL(1)FI(1)FR(2)DE(3)NO(2)BE(1)RO(3)IT(2)GB(2)PL(4)ES(1)ZA(5)