Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head (AVN-13)
Primary Purpose
Osteonecrosis
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
core decompression
Sponsored by
About this trial
This is an interventional treatment trial for Osteonecrosis focused on measuring osteonecrosis, bone marrow concentrate, demineralized bone matrix, homologous lyophilized bone chips, autologous platelet rich fibrin, mesenchymal stromal cells
Eligibility 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
Sites / Locations
- 3rd Orthopaedic and Traumatologic Clinic, prevalently oncologic, Rizzoli Orthopaedic Institute
- S.S.D. Conservative Orthopaedic Surgery and Innovative Techniques, Rizzoli Orthopaedic Institute
- Orthopaedic and Traumatologic Department Policlinico di Modena
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Demineralized Bone Marrow (DBM)
Lyophilized Bone Chips (LBC)
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
Reduction of the total necrotic area by Magnetic Resonance Imaging (MRI)
Secondary Outcome Measures
Pain reduction by measurement of the Visual Analog Scale (VAS)
Functional status evaluated by Harris Hip Score (HHS) and Western Ontario McMaster Universities Arthritis Index (WOMAC)
maintenance of structural integrity of the joint by Radiography (RX)
Full Information
NCT ID
NCT01892514
First Posted
June 25, 2013
Last Updated
May 11, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT01892514
Brief Title
Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head
Acronym
AVN-13
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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis
Keywords
osteonecrosis, bone marrow concentrate, demineralized bone matrix, homologous lyophilized bone chips, autologous platelet rich fibrin, mesenchymal stromal cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Demineralized Bone Marrow (DBM)
Arm Type
Experimental
Arm Description
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)
Arm Title
Lyophilized Bone Chips (LBC)
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
core decompression
Intervention Description
core decompression of necrotic area and graft with Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)
Primary Outcome Measure Information:
Title
Reduction of the total necrotic area by Magnetic Resonance Imaging (MRI)
Time Frame
baseline, and 12 months after surgery
Secondary Outcome Measure Information:
Title
Pain reduction by measurement of the Visual Analog Scale (VAS)
Time Frame
baseline, and 6 weeks, 3, 6, 12, 24 months after surgery
Title
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
Title
maintenance of structural integrity of the joint by Radiography (RX)
Time Frame
baseline, and 6 weeks, 3, 6, 12, 24 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dante Dallari, Surgeon
Organizational Affiliation
Rizzoli Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
3rd Orthopaedic and Traumatologic Clinic, prevalently oncologic, Rizzoli Orthopaedic Institute
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
S.S.D. Conservative Orthopaedic Surgery and Innovative Techniques, Rizzoli Orthopaedic Institute
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Orthopaedic and Traumatologic Department Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
16609976
Citation
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.
Results Reference
background
PubMed Identifier
17974883
Citation
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.
Results Reference
background
Links:
URL
http://www.ior.it/remod/wp4
Description
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Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head
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