Status:
COMPLETED
Randomized Clinical Trial for the Treatment of Osteonecrosis of the Femoral Head
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Osteonecrosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 freq...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2018
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT01892514
Start Date
April 1 2013
End Date
April 1 2018
Last Update
May 12 2023
Active Locations (3)
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1
3rd Orthopaedic and Traumatologic Clinic, prevalently oncologic, Rizzoli Orthopaedic Institute
Bologna, Italy, 40136
2
S.S.D. Conservative Orthopaedic Surgery and Innovative Techniques, Rizzoli Orthopaedic Institute
Bologna, Italy, 40136
3
Orthopaedic and Traumatologic Department Policlinico di Modena
Modena, Italy, 41124