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

NCT01892514 | Completed Phase 3

• 1 other identifier: AVN-13
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

Brief 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. 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. 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).

Conditions

Osteonecrosis

Keywords

osteonecrosis; bone marrow concentrate; demineralized bone matrix; homologous lyophilized bone chips; autologous platelet rich fibrin; mesenchymal stromal cells

Outcome Measures

Primary Outcomes (1)

• Reduction of the total necrotic area by Magnetic Resonance Imaging (MRI)

  baseline, and 12 months after surgery

Secondary Outcomes (3)

• Pain reduction by measurement of the Visual Analog Scale (VAS)

  baseline, and 6 weeks, 3, 6, 12, 24 months after surgery

• Functional status evaluated by Harris Hip Score (HHS) and Western Ontario McMaster Universities Arthritis Index (WOMAC)

  baseline, and 6, 12, 24 months after surgery

• maintenance of structural integrity of the joint by Radiography (RX)

  baseline, and 6 weeks, 3, 6, 12, 24 months after surgery

Study Arms (2)

Demineralized Bone Marrow (DBM)

EXPERIMENTAL

core decompression of necrotic area and graft with a biological product based on Demineralized Bone Matrix (DBM), Platelet-Rich-Fibrin (PRF) and Concentrated Bone Marrow (CBM)

Procedure: core decompression

Lyophilized Bone Chips (LBC)

EXPERIMENTAL

core decompression of the necrotic area and graft with a biological product based on homologous Lyophilized Bone Chips (LBC), Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)

Procedure: core decompression

Interventions

core decompression PROCEDURE

core decompression of necrotic area and graft with Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)

Demineralized Bone Marrow (DBM); Lyophilized Bone Chips (LBC)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (3)

3rd Orthopaedic and Traumatologic Clinic, prevalently oncologic, Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

S.S.D. Conservative Orthopaedic Surgery and Innovative Techniques, Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

Orthopaedic and Traumatologic Department Policlinico di Modena

Modena, 41124, Italy

Location

Related Publications (2)

• Dallari D, Fini M, Stagni C, Torricelli P, Nicoli Aldini N, Giavaresi G, Cenni E, Baldini N, Cenacchi A, Bassi A, Giardino R, Fornasari PM, Giunti A. In vivo study on the healing of bone defects treated with bone marrow stromal cells, platelet-rich plasma, and freeze-dried bone allografts, alone and in combination. J Orthop Res. 2006 May;24(5):877-88. doi: 10.1002/jor.20112.

  PMID: 16609976 BACKGROUND

• Dallari D, Savarino L, Stagni C, Cenni E, Cenacchi A, Fornasari PM, Albisinni U, Rimondi E, Baldini N, Giunti A. Enhanced tibial osteotomy healing with use of bone grafts supplemented with platelet gel or platelet gel and bone marrow stromal cells. J Bone Joint Surg Am. 2007 Nov;89(11):2413-20. doi: 10.2106/JBJS.F.01026.

  PMID: 17974883 BACKGROUND

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dante Dallari, Surgeon

  Rizzoli Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 4, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

IT (3)