Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

Any etiology
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).
Patients who had undergone a previous orthopaedic treatment for traumatology interventions
...
Any etiology
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).
Patients who had undergone a previous orthopaedic treatment for traumatology interventions
Age between 18 and 60 years.

Exclusion Criterias

Patients with active neoplastic diseases.
Pregnant patients
Patients suffering from apparent local infective processes.
...
Patients with active neoplastic diseases.
Pregnant patients
Patients suffering from apparent local infective processes.
Patients with necrosis of the femoral head of advanced stages (ARCO 3A, B, C, 4).
Patients under the age of 18 years or more than 60 years.
Patients not able to provide informed consent to treatment.

Summary

Conditions
Osteonecrosis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

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 int...

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.

Inclusion Criterias

Any etiology
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).
Patients who had undergone a previous orthopaedic treatment for traumatology interventions
...
Any etiology
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).
Patients who had undergone a previous orthopaedic treatment for traumatology interventions
Age between 18 and 60 years.

Exclusion Criterias

Patients with active neoplastic diseases.
Pregnant patients
Patients suffering from apparent local infective processes.
...
Patients with active neoplastic diseases.
Pregnant patients
Patients suffering from apparent local infective processes.
Patients with necrosis of the femoral head of advanced stages (ARCO 3A, B, C, 4).
Patients under the age of 18 years or more than 60 years.
Patients not able to provide informed consent to treatment.

Locations

Modena, 41124
Bologna, 40136
Bologna, 40136
Modena, 41124
Bologna, 40136
Bologna, 40136

Tracking Information

NCT #
NCT01892514
Collaborators
Not Provided
Investigators
  • Principal Investigator: Dante Dallari, Surgeon Rizzoli Orthopaedic Institute
  • Dante Dallari, Surgeon Rizzoli Orthopaedic Institute