Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head

Rationale. In vitro study and animal models have shown that Mesenchymal Stromal Cells (MSC) have the capacity to differentiate into osteoblastic lineage and that platelet reach fibrin can represent a clinical source of growth factors, able to accelerate the processes of tissue repair. This study intend to highlight how these factors, associated to two different preparations of bone allograft, may accelerate the formation of new host bone in patients with osteonecrosis of the femoral head that represents a common condition in clinical practice with an high socio-economic impact.

Primary objective of the study is to delay or avoid total hip replacement in patients with early necrosis of the femoral head, using different methods of regenerative medicine.

Secondary end points are described below:

• To assess differences in outcome related to features, etiology and localization of the necrosis of the femoral head and to assess variation in post-operative return to daily activities.
• To characterize the osteogenetic and angiogenic potential of marrow-derived Mesenchymal Stromal Cells (MSC) in patients with avascular necrosis of the femoral head, and to correlate these features with medical history and clinical outcome.

Inclusion criteria

• Patients with necrosis of the femoral head without fracture of the subchondral bone and without flattening of the head itself (according to ARCO classification 2A, B, C).
• Age between 18 and 60 years.
• Any etiology
• Patients who had undergone a previous orthopaedic treatment for traumatology interventions

Exclusion criteria

• Patients under the age of 18 years or more than 60 years.
• Patients not able to provide informed consent to treatment.
• Patients suffering from apparent local infective processes.
• Patients with active neoplastic diseases.
• Patients with necrosis of the femoral head of advanced stages (ARCO 3A, B, C, 4).
• Pregnant patients