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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Country

City, postcode or hospital

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

Other trials in South Africa

Poland4 sites

Study site
Bialystok, 15276
Study site
Lublin, 20954
Study site
Sosnowiec, 41200
Study site
Szczecin, 71252

Other trials in Poland

Germany3 sites

Study site
Berlin, 13353
Study site
Mainz, 55131
Study site
Münster, 48149

Other trials in Germany

Romania3 sites

Study site
Bucharest, 14461
Study site
Bucharest, 21659
Study site
Bucharest, 50098

Other trials in Romania

France2 sites

Study site
Créteil, 94010
Study site
Toulouse, 31400

Other trials in France

Italy2 sites

Study site
Pavia, 27100
Study site
Roma, 00168

Other trials in Italy

Norway2 sites

Study site
Bergen, 5021
Study site
Oslo, 0407

Other trials in Norway

United Kingdom2 sites

Study site
Bristol, BS2 8HW
Study site
Norwich, NR4 7 UY

Other trials in United Kingdom

Belgium1 site

Study site
Ghent, 9000

Other trials in Belgium

Finland1 site

Study site
Turku, 20520

Other trials in Finland

Netherlands1 site

Study site
Rotterdam, 3015 GD

Other trials in Netherlands

Spain1 site

Study site
Alcalá, 28805

Other trials in Spain

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

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 groups in NCT00161616
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.

Sep 2003Aug 2008

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Recruiting
MY01 Pressure Monitoring in Adolescent Tibia Fractures
Proximal Tibia Fracture, Tibial Shaft Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
RecruitingPhase 3
Intramedullary Calcium Sulfate Antibiotic Depot
Open tíbia Fracture, Osteomyelitis Tibia
RecruitingObservational study
Comparison of Knee Muscle Function After Suprapatellar and Infrapatellar Tibial Nailing in Patients With Tibial Shaft Fractures
Tibia Fractures

All Tibial Fractures trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation
ClinicalTrials.gov ID: NCT00161616
Acronym / sponsor ID: 3100N8-400
Conditions: Tibial Fractures
Keywords: Open Diaphyseal Tibia Fractures
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 277 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2003
Primary completion: Jul 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 7 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: InductOsInductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation
B	Other	Drug: InductOsStandard of Care: Surgical fixation only

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InductOsInductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage	Drug	A, B

Primary outcome

Number of Patients With Healed Fractures
Time frame: 13 and 20 weeks
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.

1 secondary outcome

Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)
Time frame: 1 year

Results and safety

Results posted to the registry on 7 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rhBMP-2/ACS	139	113
Standard of Care	138	119

Primary outcome: Number of Patients With Healed Fractures

Time frame: 13 and 20 weeks. Number. Unit: patients

Measure	rhBMP-2/ACS n = 139	Standard of Care n = 138
Week 13 Healed	83	66
Week 13 Not healed	8	13
Week 13 No outcome	48	59
Week 20 Healed	95	92
Week 20 Not healed	29	28
Week 20 No outcome	15	18

rhBMP-2/ACS vs Standard of Care: p = 0.0541, Fisher Exact
rhBMP-2/ACS vs Standard of Care: p = 0.7983, Fisher Exact

Population analysed: All patients randomized were analyzed.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rhBMP-2/ACS	31 of ?	127 of ?	Not reported
Standard of Care	25 of ?	123 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tibial Fractures

Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
Recruiting
MY01 Pressure Monitoring in Adolescent Tibia Fractures
Proximal Tibia Fracture, Tibial Shaft Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
RecruitingPhase 3
Intramedullary Calcium Sulfate Antibiotic Depot
Open tíbia Fracture, Osteomyelitis Tibia
RecruitingObservational study
Comparison of Knee Muscle Function After Suprapatellar and Infrapatellar Tibial Nailing in Patients With Tibial Shaft Fractures
Tibia Fractures

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager principal investigator

For Germany, MedInfoDEU@wyeth.com

Trial Manager principal investigator

For Italy, descresg@wyeth.com

27 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in South Africa, Poland, Germany, Romania, France and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Healed Fractures (time frame: 13 and 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00161616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2009.