Clinical trial NCT03726918: Identification of New Predictive Osseointegration Bio-Markers of the Prosthetic Implant in Patients With OsteoArthritis
Official title: Identification of New Predictive Osseointegration Bio-Markers of the Prosthetic Implant in Patients With OsteoArthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients of age \>40 years undergoing surgery of endo or arthroplasty for osteoarthritis or ifor other causes requiring the implantation of a prosthesis

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.

Eligibility criteria: 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

Primary outcomes:
measure: miRNAs and LncRNA
timeFrame: at the time of surgery (Day0)
Secondary outcomes:
measure: Biomarkers useful for predicting the efficiency of osseointegration of the implant
timeFrame: at the time of surgery (Day0)
measure: Validation of data obtained on miRNAs and lncRNAs
timeFrame: at the time of surgery (Day0)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
state: BO
Study officials:
affiliation: Isituto Ortopedico Rizzoli
name: Gianluca Giavaresi, MD
role: STUDY_CHAIR
References:
citation: Costa V, Raimondi L, Conigliaro A, Salamanna F, Carina V, De Luca A, Bellavia D, Alessandro R, Fini M, Giavaresi G. Hypoxia-inducible factor 1Alpha 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.
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. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-F. No abstract available.
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. doi: 10.1016/s1063-4584(02)00346-1. No abstract available.
citation: Zhang M, Lygrisse K, Wang J. Role of MicroRNA in Osteoarthritis. J Arthritis. 2017 Apr;6(2):239. doi: 10.4172/2167-7921.1000239. Epub 2017 Apr 28.