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

> **NCT00409799** · PHASE2 · COMPLETED · sponsor: **Kuros Biosurgery AG** · enrollment: 208 (actual)

## Conditions studied

- Tibia Plateau Fractures

## Interventions

- **DRUG:** I-0401 (a new bone graft substitute)

## Key facts

- **NCT ID:** NCT00409799
- **Lead sponsor:** Kuros Biosurgery AG
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2006-11
- **Primary completion:** 2011-09
- **Final completion:** 2011-09
- **Target enrollment:** 208 (ACTUAL)
- **Last updated:** 2012-03-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00409799

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00409799, "Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting". Retrieved via AI Analytics 2026-07-19 from https://api.ai-analytics.org/clinical/NCT00409799. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
