Adjunctive Therapy to Treat Tibial Shaft Fractures

NCT00533793 | Completed Phase 2

• 1 other identifier: CS I-040202/01
• Study Type: interventional
• Target: 201
• Locations: 11 countries
• Sites: 47

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

Keywords

bone, tibial shaft fracture

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  short term follow-up: 6 months; long term follow-up: additional 6 months (1 year)

Study Arms (4)

SoC

ACTIVE COMPARATOR

Standard of Care

Procedure: open fracture reduction

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

Interventions

open fracture reduction PROCEDURE

internal fracture fixation: osteosynthesis plates or intra-medullary nails

SoC; SoC plus 0.133 mg/mL; SoC plus 0.4 mg/mL; SoC plus 1.0 mg/mL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kuros Biosurgery AG: lead
• Baxter BioScience: collaborator

Study Sites (49)

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

Plovdiv, 4002, Bulgaria

Location

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

Sofia, 1606, Bulgaria

Location

Czech Republic (51)

Brno, 662 50, Czechia

Location

Czech Republic (52)

Prague, 150 06, Czechia

Location

Finland (71)

Kuopio, 70211, Finland

Location

Finland (72)

Oulu, 90220, Finland

Location

Finland (70)

Turku, 20520, Finland

Location

France (14)

Dijon, 21079, France

Location

France (16)

Dunkirk, 59240, France

Location

France (15)

Limoges, 87042, France

Location

France (11)

Rouen, 76031, France

Location

Germany (50)

Göttingen, 37075, Germany

Location

Germany (43)

Kiel, 24105, Germany

Location

Germany (40)

Leipzig, 04103, Germany

Location

Germany (41)

Ludwigshafen, 67071, Germany

Location

Germany (44)

München, 81377, Germany

Location

Germany (42)

Ravensburg, 88212, Germany

Location

Germany (45)

Rostock, 18057, Germany

Location

Fovarosi Onkormanyzat Szent janos Korhaza (81)

Budapest, 1125, Hungary

Location

Hungary (54)

Debrecen, 4031, Hungary

Location

Vaszary Kolos Hospital Esztergom (78)

Esztergom, 2500, Hungary

Location

Hungary (79)

Kaposvár, 7500, Hungary

Location

Hungary (55)

Nyíregyháza, 4400, Hungary

Location

Hungary (53)

Pécs, 7632, Hungary

Location

Italy (21)

Rozzano, 20089, Italy

Location

Romania (59)

Bucharest, 014461, Romania

Location

Romania (58)

Bucharest, 041915, Romania

Location

Spitalul Universitar de Urgenta Bucuresti (87)

Bucharest, 050098, Romania

Location

Romania (57)

Cluj-Napoca, 400132, Romania

Location

Spitalul Clinic Judetean Constanta (88)

Constanța, 900591, Romania

Location

Romania (73)

Oradea, 410032, Romania

Location

Romania (74)

Sibiu, 550245, Romania

Location

Romania (56)

Timișoara, 300736, Romania

Location

Serbia (60)

Belgrade, 11000, Serbia

Location

Serbia (76)

Belgrade, 11000, Serbia

Location

Serbia (61)

Belgrade, 11080, Serbia

Location

Serbia (62)

Kragujevac, 34000, Serbia

Location

Serbia (75)

Novi Sad, 21000, Serbia

Location

Slovak Republic (65)

Banska Bysterica, 975 17, Slovakia

Location

Slovak Republic (64)

Bratislava, 833 05, Slovakia

Location

Slovak Republic (77)

Trnava, 917 75, Slovakia

Location

Slovak Republic (63)

Žilina, 012 07, Slovakia

Location

Slovenia (67)

Izola, 6310, Slovenia

Location

Slovenia (66)

Novo Mesto, 8000, Slovenia

Location

Switzerland (02)

Aarau, 5001, Switzerland

Location

Switzerland (03)

Davos, 7270, Switzerland

Location

Switzerland (01)

Lausanne, 1011, Switzerland

Location

Switzerland (04)

Lucerne, 6000, Switzerland

Location

Switzerland (05)

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Open Fracture Reduction

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Virginia Jamieson, MD

  Kuros Biosurgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

CH (5); SL (4); HU (6); SE (5); IT (1); BU (2); DE (7); CZ (2); RO (8); FR (4); FI (3)