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

• Conditions: Complications; Implant, Orthopedic

• Registration Number: NCT03369457
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Study Start: 2018-01-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16
• Primary Completion: 2019-07-01
• Study Completion: 2020-06-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of differences in Colony Forming Units (CFU) percentage	6 months	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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the adipogenic potential in the three different cell populations	1 year	Evaluation of Oil red stain. Analysis of adipogenic markers (Peroxisome proliferator-activated receptor gamma (PPAR-γ), Lipoprotein lipase (LPL))
Evaluation of the osteogenic potential in the three different cell populations	1 year	Evaluation 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 populations	1 year	Evaluation of Alcian blue stain in pellet culture. Analysis of chondrogenic markers (Collagen type II and SOX9)

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazz; 🇮🇹 Milan, Italy