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

July 30, 2021 updated by: Istituto Ortopedico Rizzoli
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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40136
        • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • non-osteoarthritis arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the time of surgery (Day0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the time of surgery (Day0)
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.
at the time of surgery (Day0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Study Chair: Gianluca Giavaresi, MD, isituto ortopedico rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2018

Primary Completion (Actual)

June 20, 2020

Study Completion (Actual)

June 20, 2020

Study Registration Dates

First Submitted

September 27, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BioPreIOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No Individual Patient Data sharing plan has been implemented

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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