Trial record 19 of 93 for:    osteonecrosis

Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head (AVN-13)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Istituto Ortopedico Rizzoli
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT01892514
First received: June 25, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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)).


Condition Intervention Phase
Osteonecrosis
Procedure: core decompression
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Treatment of Early and Advanced Osteonecrosis of the Femoral Head With Core Decompression and Grafting With Demineralized Bone Matrix (DBM) or Homologous Lyophilized Bone Chips (LBC) Together With Platelet-rich-fibrin (PRF) and Concentrated Bone Marrow (CBM)

Resource links provided by NLM:


Further study details as provided by Istituto Ortopedico Rizzoli:

Primary Outcome Measures:
  • Magnetic Resonance Imaging (MRI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    change from baseline necrosis area at 12 months


Secondary Outcome Measures:
  • Visual Analog Scale (VAS) [ Time Frame: 6 weeks, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Harris Hip Score (HHS) [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Radiography (RX) [ Time Frame: 6 weeks, 3, 6, 12, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: April 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Demineralized Bone Marrow (DBM)
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
core decompression of necrotic area and graft with Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)
Experimental: Lyophilized Bone Chips (LBC)
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
core decompression of necrotic area and graft with Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892514

Contacts
Contact: Dante Dallari, Surgeon +390516366318 dante.dallari@ior.it

Locations
Italy
Rizzoli Orthopaedic Institute Recruiting
Bologna, Italy, 40136
Principal Investigator: Dante Dallari, Dr         
Sub-Investigator: Davide Donati, Prof         
Sub-Investigator: Fabio Catani, Prof         
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Principal Investigator: Dante Dallari, Surgeon Rizzoli Orthopaedic Institute
  More Information

No publications provided

Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01892514     History of Changes
Other Study ID Numbers: AVN-13
Study First Received: June 25, 2013
Last Updated: April 9, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Istituto Ortopedico Rizzoli:
osteonecrosis
bone marrow concentrate
demineralized bone matrix
homologous lyophilized bone chips
autologous platelet rich fibrin
mesenchymal stromal cells

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014