Tibia Plateau FracturesPhase 2NCT00409799
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
A Phase 2 study testing I-0401 (a new bone graft substitute) in people with Tibia Plateau Fractures, run by Kuros Biosurgery AG at 45 sites in 9 countries.
Trial summary
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibia Plateau Fractures
- What is being tested?
- I-0401 (a new bone graft substitute)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 45 sitesin 9 countries
- Study dates
- Nov 2006to Sep 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
- Radiological evidence of a tibial plateau fracture requiring grafting
- Females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening).
Who cannot join
- Concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau.
- Active or past history of malignant tumor.
- Evidence of systemic or localized infection at time of surgery.
- Pregnant or lactating females.
Trial locations and contacts
45 sites in 9 countries.
45 sites in 9 countries
Germany8 sites
Charite, Campus Virchow Klinikum (03)
Berlin, 13353
Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11)
Duisburg, 47249
Uniklinik Göttingen (22)
Göttingen, 37075
Med. Hochschule Hannover (06)
Hanover, 30625
Universitätsklinikum Schleswig-Holstein (40)
Kiel, 24105
St.-Josef-Krankenhaus (12)
Linnich, 52441
Chirurgische Klinik der LMU (50)
München, 81366
Universitätsklinikum Münster (39)
Münster, 48149
Poland6 sites
Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36)
Krakow, 31-826
Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58)
Lodz, 93-513
SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35)
Piekary Śląskie, 41940
Katedra i Klinika Ortopedii - Traumatologii PAM (34)
Szczecin, 71252
Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60)
Warsaw, 00-909
Katedra I Klinika Ortopedii AM (29)
Warsaw, 02005
Hungary5 sites
Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21)
Budapest, 1041
Fövarosi Önkormanyzat Peterfy Sandor utcai Korhaz-Rendelöinezet es Baleseti Központ (20)
Budapest, 1081
Fovárosi Önkormányzat Szent János Kórháza és Észak (54)
Budapest, 1125
Petz Alandar County Teaching Hospital (55)
Győr, 9024
Szegedi Egyetem AOK Kari Gyogyszertar (27)
Szeged, 6725
Italy5 sites
Istituti Ortopedici Rizzoli (13)
Bologna, 40136
Fondazione Istituto San Raffaele G. Giglio di Cefalù (16)
Cefalù, 90015
A.O. Universitaria San Martino (33)
Genova, 16132
Università degli Studi di Roma "Tor Vergata" (10)
Roma, 00133
A.O. San Giovanni Oddolorata (14)
Roma, 00184
Spain5 sites
Hospital Universitario de la Princesa (18)
Madrid, 28006
Hospital FREMAP Majadahonda (17)
Madrid, 28220
Hospital Universitario Virgen de la Victoria (51)
Málaga, 29010
Hospital FREMAP Sevilla (32)
Seville, 41012
Hospital Universitario La Fe (07)
Valencia, 46009
Switzerland5 sites
Universitätsspital Basel (24)
Basel, 4031
Kantonsspital Bruderholz (25)
Bruderholz, 4101
CHUV Lausanne (02)
Lausanne, 1011
Kantonsspital Luzern (26)
Lucerne, 6000
Zurich University Hospital (01)
Zurich, Canton Zurich, 8091
France4 sites
Hopital La Cavale Blanche (19)
Brest, 29200
Hôpital de Dunkerque (30)
Dunkirk, 59380
Hôpital Central de Nancy (05)
Nancy, 54000
Hôpital Charles Nicolle (15)
Rouen, 76031
United Kingdom4 sites
N. Bristol NHS Trust + Univ. of Bristol (52)
Bristol, BS16 1LE
University Hospital of Wales (31)
Cardiff, CF14 4XW
Leeds General Infirmary (04)
Leeds, West Yorkshire, LS1 3EX
Norfolk and Norwich University Hospital (44)
Norwich, NR4 7UY
Australia3 sites
Royal Adelaide Hospital (48)
Adelaide, South Australia, 5000
Gold Coast Hospital (49)
Gold Coast, Queensland, 4215
Princess Alexandra Hospital (45)
Woollongabba, Queensland, 4102
About this study
Official title: A Phase 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting.
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.
- Conditions
- Tibia Plateau Fractures
- Being tested
- I-0401 (a new bone graft substitute)
- Keywords
- Bone graft substitute, Promotion of bone healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-0401 (a new bone graft substitute)Drug
1 time application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Experimental - high dose Receives: Drug: I-0401 (a new bone graft substitute) |
| 2 | Experimental | Experimental - low dose Receives: Drug: I-0401 (a new bone graft substitute) |
| 3 | Active comparator | Autograft Receives: Drug: I-0401 (a new bone graft substitute) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Images
Measured: All Follow-Up Visits
Secondary outcomes (5)
Clinical assessments of the fracture site
Measured: All Follow-Up Visits
Blood parameters
Measured: All Follow-Up Visits
Vital signs
Measured: At several Follow-Up visits
Questionnaires of Life
Measured: All Follow-Up Visits
Pharmacoeconomic evaluation
Measured: All Follow-Up Visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibia Plateau 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Messmer, MD, Principal investigator, Zurich University Hospital, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409799
- Sponsor's protocol ID
- CS I-040101/02
- Status last verified
- Mar 2012
- First submitted
- 8 Dec 2006
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith TO, Casey L, McNamara IR, Hing CB. Surgical fixation methods for tibial plateau fractures. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD009679. doi: 10.1002/14651858.CD009679.pub3.
PubMed 39171616
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 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting.
- ClinicalTrials.gov ID
- NCT00409799
- Acronym / sponsor ID
- CS I-040101/02
- Conditions
- Tibia Plateau Fractures
- Keywords
- Bone graft substitute, Promotion of bone healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Dec 2006 (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.
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: I-0401 (a new bone graft substitute)Experimental - high dose |
| 2 | Experimental | Drug: I-0401 (a new bone graft substitute)Experimental - low dose |
| 3 | Active comparator | Drug: I-0401 (a new bone graft substitute)Autograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Radiological evidence of a tibial plateau fracture requiring grafting
- Females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening).
Key exclusion criteria (4 listed)
- Concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau.
- Active or past history of malignant tumor.
- Evidence of systemic or localized infection at time of surgery.
- Pregnant or lactating females.
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 |
|---|---|---|
| I-0401 (a new bone graft substitute)1 time application | Drug | 1, 2, 3 |
Primary outcome
Radiographic Images
Time frame: All Follow-Up Visits
5 secondary outcomes
Clinical assessments of the fracture site
Time frame: All Follow-Up Visits
Blood parameters
Time frame: All Follow-Up Visits
Vital signs
Time frame: At several Follow-Up visits
Questionnaires of Life
Time frame: All Follow-Up Visits
Pharmacoeconomic evaluation
Time frame: All Follow-Up Visits
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.
- Derived from this study: PubMed 39171616Smith TO, Casey L, McNamara IR, Hing CB. Surgical fixation methods for tibial plateau fractures. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD009679. doi: 10.1002/14651858.CD009679.pub3.
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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.
Peter Messmer, MD principal investigator
Zurich University Hospital, Zurich, Switzerland
45 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing I-0401 (a new bone graft substitute) in people with Tibia Plateau Fractures, run by Kuros Biosurgery AG at 45 sites in 9 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 2 inclusion and 4 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 45 sites in Germany, Poland, Hungary, Italy, Spain and 4 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?
Radiographic Images (time frame: All Follow-Up Visits). 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 NCT00409799, which also lists 1 linked publication.
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.