Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01892514
Recruitment Status : Unknown
Verified October 2017 by Istituto Ortopedico Rizzoli.
Recruitment status was:  Active, not recruiting
First Posted : July 4, 2013
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE July 4, 2013
Last Update Posted Date October 30, 2017
Study Start Date  ICMJE April 2013
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2015)
Reduction of the total necrotic area by Magnetic Resonance Imaging (MRI) [ Time Frame: baseline, and 12 months after surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
Magnetic Resonance Imaging (MRI) [ Time Frame: 12 months ]
change from baseline necrosis area at 12 months
Change History Complete list of historical versions of study NCT01892514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2015)
  • Pain reduction by measurement of the Visual Analog Scale (VAS) [ Time Frame: 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) [ Time Frame: baseline, and 6, 12, 24 months after surgery ]
  • maintenance of structural integrity of the joint by Radiography (RX) [ Time Frame: baseline, and 6 weeks, 3, 6, 12, 24 months after surgery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2013)
  • Visual Analog Scale (VAS) [ Time Frame: 6 weeks, 3, 6, 12, 24 months ]
  • Harris Hip Score (HHS) [ Time Frame: 6, 12, 24 months ]
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 6, 12, 24 months ]
  • Radiography (RX) [ Time Frame: 6 weeks, 3, 6, 12, 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head
Official Title  ICMJE 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)
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. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteonecrosis
Intervention  ICMJE Procedure: core decompression
core decompression of necrotic area and graft with Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)
Study Arms  ICMJE
  • 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)
    Intervention: Procedure: core decompression
  • 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)
    Intervention: Procedure: core decompression
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 1, 2013)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01892514
Other Study ID Numbers  ICMJE AVN-13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istituto Ortopedico Rizzoli
Study Sponsor  ICMJE Istituto Ortopedico Rizzoli
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dante Dallari, Surgeon Rizzoli Orthopaedic Institute
PRS Account Istituto Ortopedico Rizzoli
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP