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Cerament Treatment of Fracture Defects

NCT01828905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2019-03-04

No results posted yet for this study

Summary

The aim of the study is to compare fracture healing, quality of life, pain, and cost of care of the use of CERAMENT™\|BONE VOID FILLER as bone graft substitute to the use of autologous cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated by internal fixation and void reconstruction.

Conditions

  • AO 41-B2 and AO 41-B3 Tibia Fractures

Interventions

DEVICE

CERAMENT™|BONE VOID FILLER

ceramic bone void filler

PROCEDURE

Autologous cancellous bone graft

autologous cancellous bone graft

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    lead OTHER

Principal Investigators

  • Pol M. Rommens, Univ.-Prof., MD · Department of Orthopaedics and Traumatology, Johannes Gutenberg University Mainz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-12-24
Completion
2018-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01828905 on ClinicalTrials.gov