Complications; Implant, Orthopedic Clinical Trial
— EMPHAOfficial title:
Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions in Hip Replacement Surgery
| NCT number | NCT03369457 |
| Other study ID # | EMPHA |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 10, 2018 |
| Est. completion date | June 14, 2020 |
The aim of hip replacement surgery is to re-establish the physiological hip function and to
obtain a stable fixation between the prosthetic components and the native bone. Commonly, the
fixation is obtained by bone ingrowth between the prosthesis and the native bone. Thus, the
quality of the patient's bone stock is essential to achieve this aim. However, several
clinical conditions may impair the bone stock; therefore, in these cases bone grafts are
necessary to improve the prosthetic fixation. The gold standard is represented by autologous
bone grafts (from iliac crest or from acetabular bone chips) or allogeneic bone grafts from
cadaveric femoral heads. Nevertheless, the osteogenic potential of multipotent cells derived
from different anatomical regions has never been examined.
Thus, the aim of this study is to isolate multipotent cells from acetabular or femoral bone
chips and from bone marrow aspirate of the same patient and to compare their osteogenic
potential. The results of this study may reveal differences, which may have a clinical
relevance for hip replacement surgery.
| Status | Recruiting |
| Enrollment | 13 |
| Est. completion date | June 14, 2020 |
| Est. primary completion date | July 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients undergoing hip replacement and affected by: 1. hip osteoarthritis 2. mild developmental dysplasia of the hip - 18 = Body Mass Index (BMI) = 30 kg/m2 Exclusion Criteria: - Rheumatoid arthritis - Patients under pharmacological treatment for bone metabolic disorders - Patient affected by metabolic disorders, which may affect bone metabolism - Presence of bone metastases - Presence of bone infections - Patients undergoing hip revision surgeries - Obesity (BMI =30kg/m2) |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS Istituto Ortopedico Galeazz | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| Istituto Ortopedico Galeazzi |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of differences in Colony Forming Units (CFU) percentage | Formation of CFUs will be evaluated in the three different samples (acetabular bone chips, femoral bone chis or bone marrow aspirated) and CFUs will be counted in each sample | 6 months | |
| Secondary | Evaluation of the osteogenic potential in the three different cell populations | Evaluation of Alizarin red stain. Analysis of bone markers (RUNX2, Collagen type I, Collagen type X, Alkaline Phosphatase) | 1 year | |
| Secondary | Evaluation of the chondrogenic potential in the three different cell populations | Evaluation of Alcian blue stain in pellet culture. Analysis of chondrogenic markers (Collagen type II and SOX9) | 1 year | |
| Secondary | Evaluation of the adipogenic potential in the three different cell populations | Evaluation of Oil red stain. Analysis of adipogenic markers (Peroxisome proliferator-activated receptor gamma (PPAR-?), Lipoprotein lipase (LPL)) | 1 year |