Osteonecrosis Clinical Trial
— AVN-13Official 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)
NCT number | NCT01892514 |
Other study ID # | AVN-13 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | April 2013 |
Est. completion date | April 2018 |
Verified date | May 2023 |
Source | Istituto Ortopedico Rizzoli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)).
Status | Completed |
Enrollment | 104 |
Est. completion date | April 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | 3rd Orthopaedic and Traumatologic Clinic, prevalently oncologic, Rizzoli Orthopaedic Institute | Bologna | |
Italy | S.S.D. Conservative Orthopaedic Surgery and Innovative Techniques, Rizzoli Orthopaedic Institute | Bologna | |
Italy | Orthopaedic and Traumatologic Department Policlinico di Modena | Modena |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Italy,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of the total necrotic area by Magnetic Resonance Imaging (MRI) | baseline, and 12 months after surgery | ||
Secondary | Pain reduction by measurement of the Visual Analog Scale (VAS) | baseline, and 6 weeks, 3, 6, 12, 24 months after surgery | ||
Secondary | Functional status evaluated by Harris Hip Score (HHS) and Western Ontario McMaster Universities Arthritis Index (WOMAC) | baseline, and 6, 12, 24 months after surgery | ||
Secondary | maintenance of structural integrity of the joint by Radiography (RX) | baseline, and 6 weeks, 3, 6, 12, 24 months after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04072055 -
MOTO Post-marketing Surveillance Study
|
||
Terminated |
NCT02941666 -
Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip
|
||
Terminated |
NCT01763684 -
Oxford Signature vs. Conventional Global Study
|
N/A | |
Completed |
NCT00505219 -
Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head
|
Phase 3 | |
Withdrawn |
NCT02632903 -
Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
|
Phase 2 | |
Active, not recruiting |
NCT01458782 -
ACI-C Versus AMIC. A Randomized Trial Comparing Two Methods for Repair of Cartilage Defects in the Knee
|
N/A | |
Completed |
NCT01583465 -
Efficacy of Aquamantys for Reducing Transfusions With Anterior Supine Intermuscular Approach Total Hip Arthroplasty
|
N/A | |
Active, not recruiting |
NCT04401267 -
Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma
|
Phase 2 | |
Completed |
NCT03197623 -
Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids
|
Phase 1 | |
Active, not recruiting |
NCT05283148 -
Sickle Cell Disease (SCD) Bone Pain Study
|
N/A | |
Completed |
NCT05684588 -
Post-COVID-19 Sequelae: Osteonecrosis of Femoral Head
|
N/A | |
Terminated |
NCT03269409 -
Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis
|
Phase 1 | |
Completed |
NCT00913679 -
A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty
|
N/A | |
Enrolling by invitation |
NCT02893293 -
Imaging of Osteonecrosis With Ferumoxytol-Enhanced MRI
|
Phase 4 | |
Completed |
NCT01345097 -
A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
|
Phase 4 | |
Recruiting |
NCT00260897 -
Molecular Genetic Study of Avascular Necrosis of the Femoral Head
|
N/A | |
Not yet recruiting |
NCT06016634 -
Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
|
Phase 2 | |
Completed |
NCT02077647 -
Focused Registry on the Conservative Treatment of Osteoarthritis of the Knee
|
||
Recruiting |
NCT01619124 -
Osteonecroses in Pediatric Patients With ALL
|
N/A | |
Completed |
NCT02458937 -
Functional Outcomes Following Hip Core Decompression in Younger Participants With Osteonecrosis
|