Complications; Implant, OrthopedicEMPHANCT03369457
Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions
An observational study of Complications; Implant, Orthopedic, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Complications; Implant, Orthopedic
- What is being tested?
- Isolation of multipotent cells
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2018to 14 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 13 patients undergoing hip replacement surgery will be selected. Samples from acetabulum, proximal femur (head of the femur) and from bone marrow will be collected for each patient.
Who may be able to join
- Patients undergoing hip replacement and affected by:
- hip osteoarthritis
- mild developmental dysplasia of the hip
- 18 ≤ Body Mass Index (BMI) ≤ 30 kg/m2
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazz
Milan, 20161
Laura Mangiavini
About this study
Official title: Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions in Hip Replacement Surgery
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.
- Conditions
- Complications; Implant, Orthopedic
- Being tested
- Isolation of multipotent cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation of multipotent cellsBiological
Isolation of multipotent cells from patient's cells. Analysis of CFU and differentiation potential
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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)
Measured: 1 year
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)
Measured: 1 year
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-γ), Lipoprotein lipase (LPL))
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start10 Jan 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion14 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complications; Implant, OrthopedicStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Mangiavini, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369457
- Sponsor's protocol ID
- EMPHA
- Acronym
- EMPHA
- Status last verified
- Apr 2019
- First submitted
- 6 Dec 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen VT, Tessaro I, Marmotti A, Sirtori C, Peretti GM, Mangiavini L. Does the Harvesting Site Influence the Osteogenic Potential of Mesenchymal Stem Cells? Stem Cells Int. 2019 May 2;2019:9178436. doi: 10.1155/2019/9178436. eCollection 2019.
PubMed 31191688
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions in Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT03369457
- Acronym / sponsor ID
- EMPHA / EMPHA
- Conditions
- Complications; Implant, Orthopedic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 14 Jun 2020 (estimated)
- First posted
- 12 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 13 patients undergoing hip replacement surgery will be selected. Samples from acetabulum, proximal femur (head of the femur) and from bone marrow will be collected for each patient.
Key inclusion criteria (4 listed)
- Patients undergoing hip replacement and affected by:
- 18 ≤ Body Mass Index (BMI) ≤ 30 kg/m2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolation of multipotent cellsIsolation of multipotent cells from patient's cells. Analysis of CFU and differentiation potential | Biological | – |
Primary outcome
Evaluation of differences in Colony Forming Units (CFU) percentage
Time frame: 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
3 secondary outcomes
Evaluation of the osteogenic potential in the three different cell populations
Time frame: 1 year
Evaluation of the chondrogenic potential in the three different cell populations
Time frame: 1 year
Evaluation of the adipogenic potential in the three different cell populations
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 31191688Nguyen VT, Tessaro I, Marmotti A, Sirtori C, Peretti GM, Mangiavini L. Does the Harvesting Site Influence the Osteogenic Potential of Mesenchymal Stem Cells? Stem Cells Int. 2019 May 2;2019:9178436. doi: 10.1155/2019/9178436. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Complications; Implant, Orthopedic
Active, not recruitingObservational study
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Osteolysis, Arthroplasty Complications
RecruitingObservational study
Pediatric Orthopaedic Implant Safety & Efficacy
Fracture, Lengthening; Leg
Recruiting
Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?
Arthroplasty Complications, Shoulder Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Mangiavini principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications; Implant, Orthopedic, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Mangiavini, Dr (00390266214930, laura.mangiavini@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of differences in Colony Forming Units (CFU) percentage (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03369457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.