Adjunctive Therapy to Treat Tibial Shaft Fractures

NCT ID: NCT00533793

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2011-05-31

Brief 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.

Conditions

Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SoC

Standard of Care

Group Type: ACTIVE_COMPARATOR

open fracture reduction

Intervention Type: PROCEDURE

internal fracture fixation: osteosynthesis plates or intra-medullary nails

SoC plus 0.133 mg/mL

Group Type: ACTIVE_COMPARATOR

open fracture reduction

Intervention Type: PROCEDURE

internal fracture fixation: osteosynthesis plates or intra-medullary nails

SoC plus 0.4 mg/mL

Group Type: ACTIVE_COMPARATOR

open fracture reduction

Intervention Type: PROCEDURE

internal fracture fixation: osteosynthesis plates or intra-medullary nails

SoC plus 1.0 mg/mL

Group Type: ACTIVE_COMPARATOR

open fracture reduction

Intervention Type: PROCEDURE

internal fracture fixation: osteosynthesis plates or intra-medullary nails

Interventions

open fracture reduction

internal fracture fixation: osteosynthesis plates or intra-medullary nails

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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

3. male and female patients >= 18 years

4. body mass index (BMI) 16-33 (minimum body weight 50 kg, maximum 140 kg)

5. females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening)

6. 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

7. willingness and ability to understand, participate and comply with the study requirements

8. patient be able to give consent personally and sign the Informed Consent Form.

Exclusion Criteria

1. IIIc open fracture according to the Gustilo-Anderson classification

2. tibial defects requiring bone-grafting (e.g. large segmental defects)

3. duration from trauma to surgery longer than 14 days

4. 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

5. concomitant ipsilateral tibial fractures other than in the diaphyseal region

6. evidence of immune suppression

7. suspected or known hypersensitivity to the study medication or components of it

8. evidence of hypercalcemia

9. hyperparathyroidism

10. on treatment and/or planned treatment with products containing PTH (e.g. Forteo)

11. pregnant or lactating females

12. participation in another clinical trial within the last 3 months

13. active or past history of malignant tumor

14. history or evidence for any hereditary or acquired chronic metabolic bone disease other than primary osteoporosis.

15. 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

16. known history of allergy to anaesthetics

17. evidence of moderate or severe renal failure (serum creatinine > 3.0 times ULN, NCI CTC grades 3 and 4)

18. known history of allergic thrombocytopenia (type II) induced by heparin

19. inexplicable elevations of alkaline phosphatase or alkaline phosphatase > 5.0 times ULN, NCI CTC grades 3 and 4

20. prior external beam or implant radiation therapy to the skeleton

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter BioScience

INDUSTRY

Sponsor Role: collaborator

Kuros Biosurgery AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia Jamieson, MD

Role: STUDY_DIRECTOR

Kuros Biosurgery

Locations

MHAT ''Sveti Georgi'', Orthopaedic and Traumatology clinic (85)

Plovdiv, , Bulgaria

MHATEM ''N.I.Pirogov'' Second clinic of Orthopaedic and Traumatology (84)

Sofia, , Bulgaria

Czech Republic (51)

Brno, , Czechia

Czech Republic (52)

Prague, , Czechia

Finland (71)

Kuopio, , Finland

Finland (72)

Oulu, , Finland

Finland (70)

Turku, , Finland

France (14)

Dijon, , France

France (16)

Dunkirk, , France

France (15)

Limoges, , France

France (11)

Rouen, , France

Germany (50)

Göttingen, , Germany

Germany (43)

Kiel, , Germany

Germany (40)

Leipzig, , Germany

Germany (41)

Ludwigshafen, , Germany

Germany (44)

München, , Germany

Germany (42)

Ravensburg, , Germany

Germany (45)

Rostock, , Germany

Fovarosi Onkormanyzat Szent janos Korhaza (81)

Budapest, , Hungary

Hungary (54)

Debrecen, , Hungary

Vaszary Kolos Hospital Esztergom (78)

Esztergom, , Hungary

Hungary (79)

Kaposvár, , Hungary

Hungary (55)

Nyíregyháza, , Hungary

Hungary (53)

Pécs, , Hungary

Italy (21)

Rozzano, , Italy

Romania (59)

Bucharest, , Romania

Romania (58)

Bucharest, , Romania

Spitalul Universitar de Urgenta Bucuresti (87)

Bucharest, , Romania

Romania (57)

Cluj-Napoca, , Romania

Spitalul Clinic Judetean Constanta (88)

Constanța, , Romania

Romania (73)

Oradea, , Romania

Romania (74)

Sibiu, , Romania

Romania (56)

Timișoara, , Romania

Serbia (60)

Belgrade, , Serbia

Serbia (76)

Belgrade, , Serbia

Serbia (61)

Belgrade, , Serbia

Serbia (62)

Kragujevac, , Serbia

Serbia (75)

Novi Sad, , Serbia

Slovak Republic (65)

Banska Bysterica, , Slovakia

Slovak Republic (64)

Bratislava, , Slovakia

Slovak Republic (77)

Trnava, , Slovakia

Slovak Republic (63)

Žilina, , Slovakia

Slovenia (67)

Izola, , Slovenia

Slovenia (66)

Novo Mesto, , Slovenia

Switzerland (02)

Aarau, , Switzerland

Switzerland (03)

Davos, , Switzerland

Switzerland (01)

Lausanne, , Switzerland

Switzerland (04)

Lucerne, , Switzerland

Switzerland (05)

Sankt Gallen, , Switzerland

Countries

Bulgaria; Czechia; Finland; France; Germany; Hungary; Italy; Romania; Serbia; Slovakia; Slovenia; Switzerland

Other Identifiers

CS I-040202/01

Identifier Type: -

Identifier Source: org_study_id