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

NCT ID: NCT03726918

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-14

Study Completion Date

2020-06-20

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Osteoarthritis

Surgery for implantation of a prosthesis in case of Osteoarthritis

Surgery for implantation of a prosthesis

Intervention Type PROCEDURE

Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes

Non Osteoarthritis

Surgery for implantation of a prosthesis fon non Osteoarthritis cases

Surgery for implantation of a prosthesis

Intervention Type PROCEDURE

Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes

Interventions

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Surgery for implantation of a prosthesis

Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes

Intervention Type PROCEDURE

Other Intervention Names

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non-osteoarthritis arm

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gianluca Giavaresi, MD

Role: STUDY_CHAIR

Isituto Ortopedico Rizzoli

Locations

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IRCCS Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 29111380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11407681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12681957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28758052 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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BioPreIOA

Identifier Type: -

Identifier Source: org_study_id

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