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OpenTrials
Completed

NCT Number: NCT03726918

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

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)

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Interval of at least three months from any previous infiltrative treatment of any kind;
  • Patients able to provide written informed consent to the study.

Exclusion criteria

  • Severe cognitive defects or psychiatric disorders;
  • Tumor pathologies or concurrent antineoplastic therapies;
  • Autoimmune diseases (rheumatoid arthritis);
  • Surgery that involves the joint

Treatment and study plan

Surgery for implantation of a prosthesis

Procedure

Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes

Other names: non-osteoarthritis arm

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: BioPreIOA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2018
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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