Validation of Laboratory Test for Predicting Bone Tissue Regeneration (Rebone-test)
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|ClinicalTrials.gov Identifier: NCT01362413|
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : March 30, 2015
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.
|Condition or disease|
|Nonunion of Fracture [Pseudarthrosis], Site Unspecified|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Validation of Laboratory Test for Predicting Bone Tissue Regeneration in Patient Affected by Aseptic Pseudarthrosis and Treated With Platelet Gel|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2014|
- Correlation between laboratory results at the surgery and clinical and radiographic results at 12 months, when patients will be considered as healed or not healed. [ Time Frame: 13 months, for each patient ]
The pro-osteogenic ability of autologous serum will be evaluated by using a bioactivity test (mineralization assay). For this purpose serum samples will be collected 1 day before the surgery and used for culturing osteogenic cells. The ability of inducing the mineralization will be assessed after 10 days of culture.
At 12 months, clinical outcome will be evaluated as follows:
- anteroposterior and lateral X-rays to assess the continuity of bone in the various plans;
- semeiotics of the consolidation;
- assessment of pain during loading (Visual Analogue Scale).
- Assessment of the pro-osteogenic properties of serum over time. [ Time Frame: 1 month before surgery ]
In order to determine whether the pro-osteogenic properties are maintained over time, we planned to collect other serum samples, namely preoperatively, 1 month before the surgery.
The pro-osteogenic activity will be evaluated as previously described.
- Correlation between laboratory testing and timing of healing. [ Time Frame: 1, 3, 6, and 9 months postoperatively ]Clinical and radiographic results will be assessed at intermediate end points, as previously described.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362413
|Istituto Ortopedico Rizzoli|
|Bologna, Italy, 40136|
|Principal Investigator:||Donatella Granchi, MD||Laboratorio di Fisiopatologia Ortopedica e Medicina Rigenerativa - Istituto Ortopedico Rizzoli|
|Principal Investigator:||Dante Dallari, MD||Centro di Riferimento Specialistico di Applicazioni Cliniche di Medicina Rigenerativa in Ortopedia - Istituto Ortopedico Rizzoli|