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Validation of Laboratory Test for Predicting Bone Tissue Regeneration

NCT01362413 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2015-03-30

No results posted yet for this study

Summary

The aim of the study is to determine whether the evaluation of pro-osteogenic activity of autologous serum may predict the effectiveness of platelet gel in regenerating bone tissue in patients with nonunions of long bones.

Serum samples will be collected before the surgery, and their pro-osteogenic activity will be evaluated by using a bioactivity test (mineralization assay).

In order to determine whether the pro-osteogenic activity of the serum is able to discriminate between individuals who will achieve or will not achieve bone consolidation, the laboratory results will be correlated with clinical and radiographic results at 12 months, when patients will be considered as healed or not healed.

Conditions

  • Nonunion of Fracture [Pseudarthrosis], Site Unspecified

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Donatella Granchi, MD · Laboratorio di Fisiopatologia Ortopedica e Medicina Rigenerativa - Istituto Ortopedico Rizzoli

  • Dante Dallari, MD · Centro di Riferimento Specialistico di Applicazioni Cliniche di Medicina Rigenerativa in Ortopedia - Istituto Ortopedico Rizzoli

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-06-30
Completion
2014-06-30

Countries

  • Italy

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 NCT01362413 on ClinicalTrials.gov