CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01362413
NCT01362413N/ACompleted

Validation of Laboratory Test for Predicting Bone Tissue Regeneration in Patient Affected by Aseptic Pseudarthrosis and Treated With Platelet Gel

Istituto Ortopedico Rizzoli·observational·Posted May 30, 2011·Updated Mar 30, 2015

In Brief

An observational study for Nonunion of Fracture [Pseudarthrosis], Site Unspecified. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2011
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.1 years ago