Non Traumatic Osteonecrosis of the Femoral Head (Hip)
Conditions
Keywords
osteonecrosis, cell-based therapy, bone marrow, mesenchymal stem cell, hip, core decompression
Brief summary
In stage 3 Osteonecrosis (ON) of the femoral head, a beneficial effect of bone marrow grafting was reported with a reduction of the functional evolution and the necessity of a total prosthesis placement in a non-controlled retrospective trial. Based on this experience, the investigators would like to start a randomized controlled double blind study on the effect of autologous implantation of autologous bone marrow cells into the necrotic lesion of stage 3 ON of the femoral head.
Interventions
PROCEDUREcore decompression with autologous bone marrow implantation
core biopsy with injection of 40 ml concentrated autologous bone marrow.
PROCEDUREcore decompression of the femoral head
core biopsy with injection of 40 ml saline solution in place of bone marrow.
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. patients who have a non traumatic ON of the femoral head 2. Stage 3 ON (subchondral fracture). 3. Age \> 18 years 4. Be able and willing to participate in the study
Exclusion criteria
1. evidence of malignant disorder in the past five years 2. Patient unable to undergo a MRI. 3. Patient who is positive for an HIV, hepatitis B or C infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction of total prosthesis | 24, 60 months | Need to undergo a surgical treatment total prosthesis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction | 24, 60 months | Visual analogue scale |
| functional status | 24, 60 months | Lequesne and WOMAC scores |
Countries
Belgium
Outcome results
None listed