Tibial FracturesPhase 4NCT00161616
Study Evaluating InductOs in Diaphyseal Tibia Fractures
A Phase 4 study testing InductOs in people with Tibial Fractures, run by Wyeth is now a wholly owned subsidiary of Pfizer at 27 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- InductOs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 27 sitesin 12 countries
- Study dates
- Sep 2003to Aug 2008
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
27 sites in 12 countries.
27 sites in 12 countries
South Africa5 sites
Study site
Bloemfontein, 9300
Study site
Cape Town, 7505
Study site
Cape Town, 7925
Study site
Centurion, 0157
Study site
Durban
Poland4 sites
Study site
Bialystok, 15276
Study site
Lublin, 20954
Study site
Sosnowiec, 41200
Study site
Szczecin, 71252
Germany3 sites
Study site
Berlin, 13353
Study site
Mainz, 55131
Study site
Münster, 48149
Romania3 sites
Study site
Bucharest, 14461
Study site
Bucharest, 21659
Study site
Bucharest, 50098
United Kingdom2 sites
Study site
Bristol, BS2 8HW
Study site
Norwich, NR4 7 UY
About this study
Official title: 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.
- Conditions
- Tibial Fractures
- Being tested
- InductOs
- Keywords
- Open Diaphyseal Tibia Fractures
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InductOsDrug
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation Receives: Drug: InductOs |
| B | Other | Standard of Care: Surgical fixation only Receives: Drug: InductOs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 and 20 weeks
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Germany, MedInfoDEU@wyeth.comTrial Manager, Principal investigator, For Italy, descresg@wyeth.comTrial Manager, Principal investigator, For South Africa, ZAFinfo@wyeth.comTrial Manager, Principal investigator, For Norway, Finland, MedInfoNord@wyeth.comTrial Manager, Principal investigator, For Spain, infomed@wyeth.comTrial Manager, Study chair, For UK/Great Britian, ukmedinfo@wyeth.comTrial Manager, Principal investigator, For Belgium, trials-BEL@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161616
- Sponsor's protocol ID
- 3100N8-400
- Status last verified
- Jul 2009
- First submitted
- 7 Sep 2005
- Last updated
- 7 Sep 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No