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Identification of New Predictive Osseointegration Bio-Markers of the Prosthetic Implant in Patients With OsteoArthritis (BioPreIOA)

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ClinicalTrials.gov Identifier: NCT03726918
Recruitment Status : Not yet recruiting
First Posted : November 1, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Brief Summary:
The study involves the isolation and cellular, molecular and proteomic characterization of synoviocytes, osteoblasts and chondrocytes from tissue samples obtained from patients undergoing surgery of endo or arthroplasty for osteoarthritis (Experimental Group) or interventions for other causes such as for example periarticular fracture requiring the implantation of a prosthesis (Control Group)

Condition or disease Intervention/treatment
Osteoarthritis Procedure: Surgery for implantation of a prosthesis

Detailed Description:
The study involves the isolation and cellular, molecular and proteomic characterization of synoviocytes, osteoblasts and chondrocytes from tissue samples obtained from patients undergoing surgery of endo or arthroplasty for osteoarthritis (Experimental Group) or interventions for other causes such as for example periarticular fracture requiring the implantation of a prosthesis (Control Group) Deeper analysis of micro Ribo Nucleic Acid (RNA) and Non Coding RNA expressed by the synoviocytes, osteoblasts and chondrocytes will be performed in order to understand their possible involvement in pathways of osteogenic differentiation, through suitable experimental in vitro models of co-cultures. In particular, investigators will focus on the cross-talk between synoviocytes and osteoblasts, cell populations involved in the post-surgical articular microenvironment and on which the osteointegration process of the joint prosthesis depends.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of New Predictive Osseointegration Bio-Markers of the Prosthetic Implant in Patients With OsteoArthritis
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort Intervention/treatment
Osteoarthritis
Surgery for implantation of a prosthesis in case of Osteoarthritis
Procedure: Surgery for implantation of a prosthesis
Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes
Other Name: non-osteoarthritis arm

Non Osteoarthritis
Surgery for implantation of a prosthesis fon non Osteoarthritis cases
Procedure: Surgery for implantation of a prosthesis
Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes
Other Name: non-osteoarthritis arm




Primary Outcome Measures :
  1. miRNAs and LncRNA [ Time Frame: at the time of surgery (Day0) ]
    expression of miRNAs and LncRNA, from synoviocytes, osteoblasts and chondrocytes detected at the time of surgery


Secondary Outcome Measures :
  1. Biomarkers useful for predicting the efficiency of osseointegration of the implant [ Time Frame: at the time of surgery (Day0) ]
    the mRNAs and the identified proteins will be analyzed through the use of specific software, such as TargetScanPrediction.

  2. Validation of data obtained on miRNAs and lncRNAs [ Time Frame: at the time of surgery (Day0) ]
    Through in vitro co-culture systems, investigators will evaluate the role of previously identified miRNAs and lncRNAs in cross-talk between osteoblasts and synoviocytes isolated from patients with osteoarthritis.


Biospecimen Retention:   Samples With DNA
The isolated cells of synoviocytes, osteoblasts and chondrocytes from tissue samples


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients of age >40 years undergoing surgery of endo or arthroplasty for osteoarthritis or ifor other causes requiring the implantation of a prosthesis
Criteria

Inclusion Criteria:

  1. Male and Female patients > 40 years old hospitalized for surgery of endo- or arthroplasty for Osteoarthritis or for surgery for joint traumatic diseases (eg femoral neck fractures) requiring the implantation of a prosthesis
  2. Interval of at least three months from any previous infiltrative treatment of any kind;
  3. Patients able to provide written informed consent to the study.

Exclusion Criteria:

  1. Severe cognitive defects or psychiatric disorders;
  2. Tumor pathologies or concurrent antineoplastic therapies;
  3. Autoimmune diseases (rheumatoid arthritis);
  4. Surgery that involves the joint

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726918


Contacts
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Contact: Viviana Costa, PhD 00390916554 ext 630 viviana.costa@ior.it

Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Study Chair: Gianluca Giavaresi, MD Isituto Ortopedico Rizzoli
  Study Documents (Full-Text)

Documents provided by Istituto Ortopedico Rizzoli:
Study Protocol  [PDF] April 24, 2018


Publications:
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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03726918     History of Changes
Other Study ID Numbers: BioPreIOA
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Individual Patient Data sharing plan has been implemented

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases