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

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Surgery for implantation of a prosthesis

• Registration Number: NCT03726918
• Lead Sponsor: 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)

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 Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-11-01
• Study Start: 2018-12-14
• Primary Completion: 2020-06-20
• Study Completion: 2020-06-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteoarthritis	Surgery for implantation of a prosthesis	Surgery for implantation of a prosthesis in case of Osteoarthritis
Non Osteoarthritis	Surgery for implantation of a prosthesis	Surgery for implantation of a prosthesis fon non Osteoarthritis cases

Primary Outcome Measures

Name	Time	Method
miRNAs and LncRNA	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

Name	Time	Method
Biomarkers useful for predicting the efficiency of osseointegration of the implant	at the time of surgery (Day0)	the mRNAs and the identified proteins will be analyzed through the use of specific software, such as TargetScanPrediction.
Validation of data obtained on miRNAs and lncRNAs	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.

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy