Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head
Condition: Osteonecrosis
MeSH terms: Osteonecrosis; Legg-Calve-Perthes Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Femoral head avascular necrosis is a relatively common disease (10,000 - 20,000 yearly new
      United States of America cases) characterized by ischemic cell necrosis in a hip proximal
      epiphysis area frequently requiring total Hip Arthroplasty (THA).

      Even though THA resolves symptoms and restores good joint function, young patients are prone
      to major disabilities and require prosthesis revision surgeries.

      In this clinical trial a comparison between two groups of patients, treated with the same
      procedure but with two different regenerative techniques, will be performed:

        1. 52 patients with necrosis in an early stage, without deformity of the femoral epiphysis
           (stage 2A-B-C in Association for Research on Osseous Circulation (ARCO) classification,
           will undergo wide decompression of the necrotic area and reconstruction with homologous
           Lyophilized Bone Chips (LBC), growth factors from platelet concentrate Platelet-Rich
           Fibrin (PRF) and Concentrated Bone Marrow (CBM).

        2. 52 patients with necrosis of similar features, without deformity of the femoral
           epiphysis, will undergo wide decompression of the necrotic area and reconstruction with
           Demineralized Bone Matrix (DBM), growth factors from Platelet-Rich-Fibrin (PRF) and
           Concentrated Bone Marrow (CBM).

      Patients will be evaluated post-surgery at 6 weeks, 3, 6, 12, and 24 months to assess joint
      damage evolution by ARCO classification, and hip function by clinical scores (Harris Hip
      Score (HHS), Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score, and
      Visual Analogic Scale (VAS)).
    

Detailed description: 
      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.
    

Intervention name(s): core decompression
Intervention type(s): Procedure
Intervention description(s): core decompression of necrotic area and graft with Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteonecrosis; bone marrow concentrate; demineralized bone matrix; homologous lyophilized bone chips; autologous platelet rich fibrin; mesenchymal stromal cells