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

Osteoarthritis Clinical Trial

— BioPreIOA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03726918
• Other study ID #: BioPreIOA
• Status: Completed
• Start date: December 14, 2018
• Est. completion date: June 20, 2020

Study information

• Verified date: July 2021
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 20, 2020
• Est. primary completion date: June 20, 2020
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Surgery for implantation of a prosthesis
Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Costa V, Raimondi L, Conigliaro A, Salamanna F, Carina V, De Luca A, Bellavia D, Alessandro R, Fini M, Giavaresi G. Hypoxia-inducible factor 1? may regulate the commitment of mesenchymal stromal cells toward angio-osteogenesis by mirna-675-5P. Cytotherapy. 2017 Dec;19(12):1412-1425. doi: 10.1016/j.jcyt.2017.09.007. Epub 2017 Oct 27. — View Citation

Marijnissen AC, Lafeber FP. Re: E. B. Hunziker. Articular cartilage repair: basic science and clinical progress. A review of the current status and prospects. Osteoarthritis and Cartilage 2002; 10:432-63. Osteoarthritis Cartilage. 2003 Apr;11(4):300-1; author reply 302-4. — View Citation

Pelletier JP, Martel-Pelletier J, Abramson SB. Osteoarthritis, an inflammatory disease: potential implication for the selection of new therapeutic targets. Arthritis Rheum. 2001 Jun;44(6):1237-47. Review. — View Citation

Zhang M, Lygrisse K, Wang J. Role of MicroRNA in Osteoarthritis. J Arthritis. 2017 Apr;6(2). pii: 239. doi: 10.4172/2167-7921.1000239. Epub 2017 Apr 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miRNAs and LncRNA	expression of miRNAs and LncRNA, from synoviocytes, osteoblasts and chondrocytes detected at the time of surgery	at the time of surgery (Day0)
Secondary	Biomarkers useful for predicting the efficiency of osseointegration of the implant	the mRNAs and the identified proteins will be analyzed through the use of specific software, such as TargetScanPrediction.	at the time of surgery (Day0)
Secondary	Validation of data obtained on miRNAs and lncRNAs	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)