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Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions

Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions in Hip Replacement Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03369457
Acronym
EMPHA
Enrollment
13
Registered
2017-12-12
Start date
2018-01-10
Completion date
2020-06-14
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications; Implant, Orthopedic

Brief summary

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.

Interventions

BIOLOGICALIsolation of multipotent cells

Isolation of multipotent cells from patient's cells. Analysis of CFU and differentiation potential

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of differences in Colony Forming Units (CFU) percentage6 monthsFormation 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

Secondary

MeasureTime frameDescription
Evaluation of the osteogenic potential in the three different cell populations1 yearEvaluation of Alizarin red stain. Analysis of bone markers (RUNX2, Collagen type I, Collagen type X, Alkaline Phosphatase)
Evaluation of the chondrogenic potential in the three different cell populations1 yearEvaluation of Alcian blue stain in pellet culture. Analysis of chondrogenic markers (Collagen type II and SOX9)
Evaluation of the adipogenic potential in the three different cell populations1 yearEvaluation of Oil red stain. Analysis of adipogenic markers (Peroxisome proliferator-activated receptor gamma (PPAR-γ), Lipoprotein lipase (LPL))

Countries

Italy

Contacts

Primary ContactLaura Mangiavini, Dr
laura.mangiavini@grupposandonato.it00390266214930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026