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Validation of Laboratory Test for Predicting Bone Tissue Regeneration (Rebone-test)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362413
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Brief 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.


Condition or disease
Nonunion of Fracture [Pseudarthrosis], Site Unspecified

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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
Serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

Eligible patients will be identified according to the following criteria.

Inclusion criteria:

  • patients with aseptic nonunion of long bones and candidates for treatment with platelet gel and MSC in addition to fixation devices and bone grafting;
  • patients who have given their written consent to participate in the study.

Exclusion criteria:

  • patients with bone infections;
  • patients with congenital disorders involving the skeletal development;
  • patients treated with corticosteroids or other immunosuppressive agents;
  • patients suffering from mental or psychiatric disorders that preclude the possibility of correctly adhering to the protocol.

Information from the National Library of Medicine

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


Locations
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Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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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
Additional Information:
Publications:

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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01362413    
Other Study ID Numbers: IOR 65/10
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015
Keywords provided by Istituto Ortopedico Rizzoli:
pseudarthrosis
mineralization
platelet-rich-plasma
serum
Additional relevant MeSH terms:
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Pseudarthrosis
Fractures, Ununited
Fractures, Bone
Wounds and Injuries