TraumaPhase 2TSFNCT00533793
Adjunctive Therapy to Treat Tibial Shaft Fractures
A Phase 2 study testing open fracture reduction in people with Trauma, run by Kuros Biosurgery AG at 49 sites in 12 countries.
Trial summary
A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- open fracture reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 49 sitesin 12 countries
- Study dates
- Apr 2007to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Eligible patients must meet all of the following inclusion criteria:
- patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and current radiographs indicated for open fracture reduction and internal fixation using osteosynthesis plates or intra-medullary nails
- soft tissue management (if medically warranted, eg. debridement, irrigation, application of antibiotics) performed according to local hospital practice no later than 24h after the trauma
- male and female patients >= 18 years
- body mass index (BMI) 16-33 (minimum body weight 50 kg, maximum 140 kg)
- females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening)
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- females of child-bearing potential randomized in the intervention group must agree to have acceptable contraception for at least 3 months after receiving the study medication.
- Acceptable contraceptive measures are:
- Hormonal types of birth control with a failure rate of less than 1% per year (such as implants, injections, combined oral contraceptives, patches or other methods) or copper IUDs or other IUDs with a failure rate of less than 1% per year, AND
- An additional barrier type of birth control measure (such as condoms, diaphragms, cervical caps, etc.) Sterilized women and abstinent women of child-bearing potential will not be required to take contraceptive measures
- willingness and ability to understand, participate and comply with the study requirements
- patient be able to give consent personally and sign the Informed Consent Form.
Who cannot join
- Patients will be not eligible if they meet one of the following exclusion criteria:
- IIIc open fracture according to the Gustilo-Anderson classification
- tibial defects requiring bone-grafting (e.g. large segmental defects)
- duration from trauma to surgery longer than 14 days
- concomitant acute bone injuries and/or major skin or other significant injuries that in the opinion of the investigator would interfere with the tibial shaft fracture healing process
- concomitant ipsilateral tibial fractures other than in the diaphyseal region
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- evidence of immune suppression
- suspected or known hypersensitivity to the study medication or components of it
- evidence of hypercalcemia
- hyperparathyroidism
- on treatment and/or planned treatment with products containing PTH (e.g. Forteo)
- pregnant or lactating females
- participation in another clinical trial within the last 3 months
- active or past history of malignant tumor
- history or evidence for any hereditary or acquired chronic metabolic bone disease other than primary osteoporosis.
- history or evidence for any clinically relevant organ failure or any other relevant medical condition that, in the opinion of the investigator, will relevantly interfere with the assessment of study outcome or will impose hazard to the patient if study therapy will be initiated
- known history of allergy to anaesthetics
- evidence of moderate or severe renal failure (serum creatinine > 3.0 times ULN, NCI CTC grades 3 and 4)
- known history of allergic thrombocytopenia (type II) induced by heparin
- inexplicable elevations of alkaline phosphatase or alkaline phosphatase > 5.0 times ULN, NCI CTC grades 3 and 4
- prior external beam or implant radiation therapy to the skeleton
Trial locations and contacts
49 sites in 12 countries.
49 sites in 12 countries
Romania8 sites
Romania (59)
Bucharest, 014461
Romania (58)
Bucharest, 041915
Spitalul Universitar de Urgenta Bucuresti (87)
Bucharest, 050098
Romania (57)
Cluj-Napoca, 400132
Spitalul Clinic Judetean Constanta (88)
Constanța, 900591
Romania (73)
Oradea, 410032
Romania (74)
Sibiu, 550245
Romania (56)
Timișoara, 300736
Germany7 sites
Germany (50)
Göttingen, 37075
Germany (43)
Kiel, 24105
Germany (40)
Leipzig, 04103
Germany (41)
Ludwigshafen, 67071
Germany (44)
München, 81377
Germany (42)
Ravensburg, 88212
Germany (45)
Rostock, 18057
Hungary6 sites
Fovarosi Onkormanyzat Szent janos Korhaza (81)
Budapest, 1125
Hungary (54)
Debrecen, 4031
Vaszary Kolos Hospital Esztergom (78)
Esztergom, 2500
Hungary (79)
Kaposvár, 7500
Hungary (55)
Nyíregyháza, 4400
Hungary (53)
Pécs, 7632
Serbia5 sites
Serbia (60)
Belgrade, 11000
Serbia (76)
Belgrade, 11000
Serbia (61)
Belgrade, 11080
Serbia (62)
Kragujevac, 34000
Serbia (75)
Novi Sad, 21000
Switzerland5 sites
Switzerland (02)
Aarau, 5001
Switzerland (03)
Davos, 7270
Switzerland (01)
Lausanne, 1011
Switzerland (04)
Lucerne, 6000
Switzerland (05)
Sankt Gallen, 9007
France4 sites
France (14)
Dijon, 21079
France (16)
Dunkirk, 59240
France (15)
Limoges, 87042
France (11)
Rouen, 76031
Slovakia4 sites
Slovak Republic (65)
Banska Bysterica, 975 17
Slovak Republic (64)
Bratislava, 833 05
Slovak Republic (77)
Trnava, 917 75
Slovak Republic (63)
Žilina, 012 07
Finland3 sites
Finland (71)
Kuopio, 70211
Finland (72)
Oulu, 90220
Finland (70)
Turku, 20520
Bulgaria2 sites
MHAT ''Sveti Georgi'', Orthopaedic and Traumatology clinic (85)
Plovdiv, 4002
MHATEM ''N.I.Pirogov'' Second clinic of Orthopaedic and Traumatology (84)
Sofia, 1606
Czechia2 sites
Czech Republic (51)
Brno, 662 50
Czech Republic (52)
Prague, 150 06
About this study
Official title: A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures
A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.
- Conditions
- Trauma
- Being tested
- open fracture reduction
- Keywords
- bone, tibial shaft fracture
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open fracture reductionProcedure or surgery
internal fracture fixation: osteosynthesis plates or intra-medullary nails
| Study group | Role | What they receive |
|---|---|---|
| SoC | Active comparator | Standard of Care Receives: Procedure: open fracture reduction |
| SoC plus 0.133 mg/mL | Active comparator | Not described Receives: Procedure: open fracture reduction |
| SoC plus 0.4 mg/mL | Active comparator | Not described Receives: Procedure: open fracture reduction |
| SoC plus 1.0 mg/mL | Active comparator | Not described Receives: Procedure: open fracture reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Criteria:weight bearing,red.pain,walking without aid;lack of need for surg. interv. fracture site;Radiogr. crit.:Cortical bridging,disintegration/disappearance fracture lines,absence of signs for complications(infection,malunion)
Measured: short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year)
Secondary outcomes (1)
Prop. patients healed 3,9,12 mths after T0; prop. time, extent radiogr. union for 2,3,4,5,6,9,12 mths after T0; Eval.:6 and 12 mths; prop./invasiven. sec. interv. due to persistent non-union within 6,12 mths after T0.
Measured: short term follow-up: 6 months; long term follow-up: additional 6 months (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter BioScience
- Responsible party
- Sponsor
- Investigators
- Virginia Jamieson, MD, Study director, Kuros Biosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533793
- Sponsor's protocol ID
- CS I-040202/01
- Acronym
- TSF
- Status last verified
- Mar 2012
- First submitted
- 20 Sep 2007
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures
- ClinicalTrials.gov ID
- NCT00533793
- Acronym / sponsor ID
- TSF / CS I-040202/01
- Conditions
- Trauma
- Keywords
- bone, tibial shaft fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Collaborators
- Baxter BioScience
- Study start
- Apr 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SoC | Active comparator | Procedure: open fracture reductionStandard of Care |
| SoC plus 0.133 mg/mL | Active comparator | Procedure: open fracture reduction |
| SoC plus 0.4 mg/mL | Active comparator | Procedure: open fracture reduction |
| SoC plus 1.0 mg/mL | Active comparator | Procedure: open fracture reduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and current radiographs indicated for open fracture reduction and internal fixation using osteosynthesis plates or intra-medullary nails
- soft tissue management (if medically warranted, eg. debridement, irrigation, application of antibiotics) performed according to local hospital practice no later than 24h after the trauma
- male and female patients >= 18 years
- body mass index (BMI) 16-33 (minimum body weight 50 kg, maximum 140 kg)
- females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening)
Key exclusion criteria (21 listed)
- IIIc open fracture according to the Gustilo-Anderson classification
- tibial defects requiring bone-grafting (e.g. large segmental defects)
- duration from trauma to surgery longer than 14 days
- concomitant acute bone injuries and/or major skin or other significant injuries that in the opinion of the investigator would interfere with the tibial shaft fracture healing process
- concomitant ipsilateral tibial fractures other than in the diaphyseal region
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 |
|---|---|---|
| open fracture reductioninternal fracture fixation: osteosynthesis plates or intra-medullary nails | Procedure or surgery | SoC, SoC plus 0.133 mg/mL, SoC plus 0.4 mg/mL, SoC plus 1.0 mg/mL |
Primary outcome
Clinical Criteria:weight bearing,red.pain,walking without aid;lack of need for surg. interv. fracture site;Radiogr. crit.:Cortical bridging,disintegration/disappearance fracture lines,absence of signs for complications(infection,malunion)
Time frame: short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year)
1 secondary outcome
Prop. patients healed 3,9,12 mths after T0; prop. time, extent radiogr. union for 2,3,4,5,6,9,12 mths after T0; Eval.:6 and 12 mths; prop./invasiven. sec. interv. due to persistent non-union within 6,12 mths after T0.
Time frame: short term follow-up: 6 months; long term follow-up: additional 6 months (1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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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.
Virginia Jamieson, MD study director
Kuros Biosurgery
49 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing open fracture reduction in people with Trauma, run by Kuros Biosurgery AG at 49 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 12 inclusion and 21 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Romania, Germany, Hungary, Serbia, Switzerland 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Criteria:weight bearing,red.pain,walking without aid;lack of need for surg. interv. fracture site;Radiogr. crit.:Cortical bridging,disintegration/disappearance fracture lines,absence of signs for complications(infection,malunion) (time frame: short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2012.