Skip to main content
Clinical Trials/NCT03726918
NCT03726918
Completed
Not Applicable

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

Istituto Ortopedico Rizzoli1 site in 1 country9 target enrollmentDecember 14, 2018
ConditionsOsteoarthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
9
Locations
1
Primary Endpoint
miRNAs and LncRNA
Status
Completed
Last Updated
4 years ago

Overview

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)

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.

Registry
clinicaltrials.gov
Start Date
December 14, 2018
End Date
June 20, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Biomarkers useful for predicting the efficiency of osseointegration of the implant(at the time of surgery (Day0))
  • Validation of data obtained on miRNAs and lncRNAs(at the time of surgery (Day0))

Study Sites (1)

Loading locations...

Similar Trials