Femoral head avascular necrosis (AVN) is a progressively debilitating disease that usually leads to the destruction of the hip joint. It is a fairly common disease that is responsible for 5% to 12% of all total hip arthroplasty (THA) surgeries. Affected individuals are typically between 20 and 50 years of age, that is much younger than the typical patient requiring joint replacement surgery. Even though THA resolves symptoms and restores good joint function, young patients are prone to major disabilities and prosthetic revision may be required.

In this clinical trial two groups of patients suffering from osteonecrosis stage II (ARCO classification) are treated by core decompression plus two different regenerative techniques, involving the use of Lyophilized Bone Chips with concentrated bone marrow (CBM) and growth factor containing-platelet rich fibrin (PRF), or  Demineralized Bone Matrix with CBM and PRF.

Patients will be evaluated post-surgery at 6 weeks, 3 and 6 months, then with yearly follow-ups for up to 2 years to assess joint repair using clinical score and imaging by X-rays, Computed Tomography and Magnetic Resonance. Biological basis of repair are examined in preclinical studies analysing in vitro osteoprogenitor cell potency and in vivo using NOD-SCID mice. Pre-surgery bone defect is examined by histology.

The goal of treatment is to promote the regeneration of bone tissue in the necrotic area, so as to prevent or delay progression of joint degeneration.

Unit 1
WP Coordinator: Dante Dallari, MD, IOR
Phone +39-347-0072990     E-mail: dante.dallari@ior.it
Head of S.S.D. Conservative Orthopaedic Surgery and Innovative Techniques. He is responsible for the selection of patients, for the surgical interventions and the follow up evaluations.   

Unit 2
Unit Leader: Prof. Davide Maria Donati, IOR
Phone +39-051-6366525/523     E-mail: davide.donati@ior.it
Assistant Professor, Head of the iii Clinics of Orthopaedics and Traumatology, and manager of the Bone Regeneration Laboratory. He is responsible for the selection of patients, for the surgical interventions and the follow up evaluations.

Unit 3
Unit Leader: Prof. Fabio Catani, UniMoRe
Phone +39-051-4224309     E-mail: fabio.catani@unimore.it - fabio.catani@policlinico.mo.it
Full Professor, Head of  the Orthopaedics and Traumatology Department. He is responsible for the selection of patients, for the surgical interventions and the follow up evaluations.

Unit 4
Unit Leader: Prof. Nicola Baldini, IOR
Phone +39-051-6366748     E-mail: nicola.baldini@ior.it
Assistant Professor, Head of the S.S.D. Fisiopatologia Ortopedica e Medicina Rigenerativa. He co-ordinates the laboratory activities, including the characterization and in vitro testing of MSC, as well as the histological evaluation of bone specimens.

Unit 5
Unit Leader: Prof. Massimo Dominici, UniMoRe
Phone +39-051-4222858     E-mail: massimo.dominici@unimore.it
Assistant Professor, Medical Oncology UNIMORE and Head of Laboratory of Cell Biology and Advanced Cancer Therapies. He is responsible of the in vivo NOD-SCID model, for the evaluation of MSC in vivo performance in association with the biomaterials.