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Completed

NCT Number: NCT00409799

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

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.

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Key information

Conditions

Tibia Plateau Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Gold Coast Hospital (49), Gold Coast, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

I-0401 (a new bone graft substitute)

Drug

1 time application

Primary outcomes

  1. Radiographic Images

    Time frame: All Follow-Up Visits

Secondary outcomes

  1. Clinical assessments of the fracture site

    Time frame: All Follow-Up Visits

  2. Blood parameters

    Time frame: All Follow-Up Visits

  3. Vital signs

    Time frame: At several Follow-Up visits

  4. Questionnaires of Life

    Time frame: All Follow-Up Visits

  5. Pharmacoeconomic evaluation

    Time frame: All Follow-Up Visits

Sponsors and collaborators

Lead sponsor

Kuros Biosurgery AG

Industry

Registry information

Official study title

A Phase 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting.

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Dec 11, 2006
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.