A scientific experiment to further test the safety and efficacy of I-0401 in the treatment of patients with fractures of the upper surface of the shin bone requiring transplant bone tissue (from their own). In several centers, study subjects are randomly allocated to receive one or other of the alternative treatments under study, without being aware of the concentration received.
- Conditions
- Fractures of the tibial plateau requiring graftingMedDRA version: 13.1Level: HLTClassification code 10024956Term: Lower limb fracturesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2006-003688-30-DE
- Lead Sponsor
- Kuros Biosurgery AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
1. Radiological evidence of fracture of the tibial plateau requiring grafting and fixation that occurs either alone or is part of a polytraumatic event (AO classification: 41B2, 41B3, 41C2, 41C3).
2. Female and male subjects = 18 years.
3. Body mass index (BMI) 16-33 (minimum body weight 50 kg, maximum 140 kg).
4. Glasgow coma score (GCS) = 13.
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 I-0401.
7. Subjects must be able and willing to come to the clinic for follow up visits as scheduled in the time and events schedule.
8. Signed Informed Consent Form (ICF). The patient has to be able to give consent personally.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31
1. Total size of defect requiring a graft volume of > 7.0 mL.
2. Patients with high risk of amputation.
3. Open tibial plateau fractures Gustilo-Anderson grade III.
4. Concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau.
5. Active or past history of malignant tumor.
6. Evidence of systemic or localized infection at time of surgery.
7. Pregnant or lactating females.
8. Evidence of immune-suppression.
9. On treatment and/or planned treatment with products containing PTH (e.g. Forteo®, Forsteo®).
10. Evidence of hypercalcemia (serum calcium above ULN).
11. Known history of allergy to anesthetics.
12. Suspected or known allergies towards any of the components of I-0401 (TGplPTH1-34, Fibrin, HA/TCP granules).
13. History or evidence for a metabolic bone disease other than primary osteoporosis.
14. Known clinically significant organ or systemic diseases or any other relevant medical condition such that in the opinion of the investigator, the significance of the disease or condition will impose hazard to the patient if study therapy will be initiated or will compromise the subject’s participation in the study.
15. Participation in another clinical trial within 3 months prior to trial start.
16. Evidence of moderate or severe renal failure (serum creatinine > 3.0 times ULN, NCI CTC grades 3 and 4).
17. History of allergic thrombocytopenia (type II) induced by heparin.
18. Inexplicable elevations of alkaline phosphatase (alkaline phosphatase > 5.0 times ULN, NCI CTC grades 3 and 4).
19. Prior external beam or implant radiation therapy to the skeleton.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method