Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting

Phase 2

Completed

• Conditions: Tibia Plateau Fractures
• Interventions: Drug: I-0401 (a new bone graft substitute)

• Registration Number: NCT00409799
• Lead Sponsor: Kuros Biosurgery AG

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-08
• Study First Submitted QC: 2006-12-08
• Study First Posted: 2006-12-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	I-0401 (a new bone graft substitute)	Autograft
1	I-0401 (a new bone graft substitute)	Experimental - high dose
2	I-0401 (a new bone graft substitute)	Experimental - low dose

Primary Outcome Measures

Name	Time	Method
Radiographic Images	All Follow-Up Visits

Secondary Outcome Measures

Name	Time	Method
Clinical assessments of the fracture site	All Follow-Up Visits
Blood parameters	All Follow-Up Visits
Vital signs	At several Follow-Up visits
Questionnaires of Life	All Follow-Up Visits
Pharmacoeconomic evaluation	All Follow-Up Visits

Trial Locations

Locations (45)

Gold Coast Hospital (49); 🇦🇺 Gold Coast, Queensland, Australia

Princess Alexandra Hospital (45); 🇦🇺 Woollongabba, Queensland, Australia

Royal Adelaide Hospital (48); 🇦🇺 Adelaide, South Australia, Australia

Hopital La Cavale Blanche (19); 🇫🇷 Brest, France

Hôpital de Dunkerque (30); 🇫🇷 Dunkerque, France

Hôpital Central de Nancy (05); 🇫🇷 Nancy, France

Hôpital Charles Nicolle (15); 🇫🇷 Rouen, France

Charite, Campus Virchow Klinikum (03); 🇩🇪 Berlin, Germany

Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11); 🇩🇪 Duisburg, Germany

Uniklinik Göttingen (22); 🇩🇪 Göttingen, Germany

Scroll for more (35 remaining)