Tibia or Femur Pseudo-arthrosis
Conditions
Keywords
pseudo-arthrosis, osseous matrix, cell therapy
Brief summary
Sometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a long time. To optimize this integration we purpose to associate mesenchymal progenitors cells from autologous bone marrow.
Detailed description
All patients will be treated for tibia or femur pseudo-arthrosis. At the beginning of chirurgical intervention, autologous bone marrow will be sampling and will be concentrated during this one. Meanwhile osseous matrix (Ostéopure™ ) will be incubated in autologous blood serum and finally implanted in the fracture site. And after (at the end of chirurgical intervention), concentrate autologous bone marrow will be injected in the same place.
Interventions
PROCEDUREChirurgical procedure
Chirurgical procedure to treat pseudo-arthrosis, with of osseous matrix implantation and autologous bone marrow injection.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* tibia or femur pseudo-arthrosis, * patient who needs bone graft
Exclusion criteria
* \- contra indications for chirurgical intervention or bone graft
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate osseous setting at 3-months follow-up and compare our results with past studies | at 3-months follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility and tolerance of this therapeutic strategy | at 3-months follow-up |
Outcome results
None listed