An observational study in Nonunion of Fracture [Pseudarthrosis], Site Unspecified, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-30.
Sponsored by Istituto Ortopedico Rizzoli · Observational
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.
Pseudarthrosis (or 'nonunions') is defined as a bone movement which occurs after about 6 months from the traumatic event as consequence of the inadequate healing of a fracture. The use of regenerative medicine for treating recalcitrant pseudarthrosis is considered a promising strategy to promote bone consolidation. Among the various approaches used, the local cell therapy based on autologous mesenchymal stromal cells (MSC), combined with or without growth factors, has been extensively used. MSC reside within the stromal compartment of bone marrow which may be obtained from the iliac crest. Growth factors may be discharged from platelet gel (PG) which is obtained after activation of autologous platelet concentrates. Nevertheless, the results of recent clinical studies show that the above mentioned regenerative approach shows a failure rate of approximately 30% (Calori et al, 2008). The availability of a laboratory test which may predict the regenerative capacity of the PG may help the orthopaedic surgeon in addressing the decisions regarding the regenerative approach, e.g. to use or non use autologous platelet concentrates or to enhance the use of autologous derivatives with recombinant factors.The rationale for the use of platelet concentrates in pseudarthrosis is the significant reduction of osteoinductive growth factors observed at the lesion site (Gandhi et al., 2005). Platelet gel mimics what happens physiologically after any bone injury, when platelets are entrapped in a clot within a fibrin matrix. Platelet activation determines the release of various growth factors promoting bone healing. The optimal level and ratio of growth factors and their synergistic effects should be more efficient than single recombinant molecules, even though no data are available on the most relevant molecules and on their optimal amount. In this context, the in vitro mineralization assay could be a valid tool to assess the pro-osteogenic activity of platelet gel, thus obviating the measurement of the myriad of platelet-derived substances.
The aim of the study is to determine whether the evaluation of pro-osteogenic activity of autologous serum may predict the effectiveness of PG in the regeneration of bone tissue in patients with nonunions of long bones. The rationale is based on the following issues:
In order to evaluate the ability of the autologous serum in inducing the mineralization in vitro the investigators will use a bioactivity test (mineralization assay). For this purpose serum samples of patients candidates to the treatment with MSC and PG will be collected the day before the surgery and used for cultivating normal MSC, whose ability to mineralize in vitro will be previously verified in standard culture conditions.
Further analysis will be conducted in order to determine whether the pro-osteogenic properties are maintained over time, and serum samples will be collected the 1 month before the surgery.
In order to determine whether the pro-osteogenic activity of the serum is able to predict and discriminate between individuals who achieve or 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.
41 studies on the registry are indexed under Pseudarthrosis; 7 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 16 observational studies indexed under Pseudarthrosis.
Browse Pseudarthrosis studies →Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.
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Eligible patients will be identified according to the following criteria.
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Time frame: 13 months, for each patient
Assessment of the pro-osteogenic properties of serum over time.
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.
Time frame: 1 month before surgery
Correlation between laboratory testing and timing of healing.
Clinical and radiographic results will be assessed at intermediate end points, as previously described.
Time frame: 1, 3, 6, and 9 months postoperatively
The record gives a start of Jan 2011, a primary completion of Jun 2013 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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