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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Osteoarthritis

Treatments: Procedure: Surgery for implantation of a prosthesis

Study type: Observational

Funder types: Other

Identifiers

NCT03726918

BioPreIOA

Details and patient eligibility

About

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)

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

9 participants in 2 patient groups

Osteoarthritis

Description:

Surgery for implantation of a prosthesis in case of Osteoarthritis

Treatment:

Procedure: Surgery for implantation of a prosthesis

Non Osteoarthritis

Description:

Surgery for implantation of a prosthesis fon non Osteoarthritis cases

Treatment:

Procedure: Surgery for implantation of a prosthesis