Biological and clinical research

This Unit consists of two subgroups, the first one dedicated to the epidemiological evaluation and to the post-marketing monitoring of orthopaedic medical devices which is performed by RIPO (Register of Orthopaedic Prosthetic Implants), and the second one which studies some effects of specific joint prosthesis implantations, by the means of bone tissue, pre implantation soft tissue and biological fluids analyses.

 

Register of Orthopaedic Prosthetic Implants (R.I.P.O) and Register of Orthopaedic Prosthetic Explants (R.E.P.O)

The Register of Orthopaedic Prosthetic Implants (R.I.P.O) was initiated at the Rizzoli Orthopaedic Institutes in 1990. All the 60 Orthopaedic Units in the Emilia-Romagna region (approx. 4 milions inhabitants) joined it starting from January 2000.

At December 31st, 2012  the Register collected data of nearly 75,000 total hip-replacement, 28,000 hemiarthoplasty, 12,000 hip revisions, and 59,000 knee replacements and 1,000 shoulder replacements.
More than 95% of surgeries performed in the Emilia Romagna region are repoted to RIPO.

It consists of a database, where clinical conditions of patients, side of surgery, surgical procedure, type and fixation of implant are recorded, for either primary and revision hip, knee and shoulder prosthesis surgery. Reference code and batch number of each single implanted component is recorded. The endpoint is the revision of even a single component of the prosthesis.

More than 100 different types of commercial hip prostheses and 70 knee prostheses are followed to evaluate their outcomes.

The register co-operates with the orthopaedic surgeons and with regional authorities to define observational studies and evaluate joint prostheses or innovative techniques. Moreover, the Register is able to identify in real time the patients on whom a certain joint prosthesis was implanted. Those at risk of precocious failure on the basis of recallings made by the Ministry of Health or manufacturers can thus be identified. At this point orthopaedic surgeons may be in condition to promptly adopt all the necessary measures to defend the health of the patient.

The Register is partially funded by the Assessorship for Health and Social Politics of the Emilia-Romagna region.

The R.E.P.O. (Register of Orthopaedic Prosthetic Explants) management activity consists in collecting, archiving, analysing the medical devices explanted at the Rizzoli Orthopaedic Institute. This is aimed to conduct post-marketing monitoring studies on these devices.
During 10 years of activity more than 2,000 devices have been collected, mostly hip and knee prostheses. Devices involved in reported accidents are available to legal authorities, manufacturers and patients according to internal procedure.

Biology research

The Biology subgroup leads the following research lines, some of which in co-operation with other research structures, within and outside the Rizzoli Institute. Medical Technology Laboratory

Analyses aimed to diagnosis

  • Isolation of wear particles inside sinovial liquids and tissues of patients wearing a prosthesis, by means of SEM-EDX and morphological analysis. The SEM-EDX analyses are performed in co-operation with ITO-CNR, Unità di Bologna c/o Istituti Ortopedici Rizzoli, directed by Prof. Maraldi).
  • Dosage of metallic ions by means of ICP-AES in biological fluids of patients wearing a prosthesis (in collaboration with the University of Brescia).

Resarch

  • Cell cultures of osteoblastic and osteocytic lines, to assess the effect of physical conditions (loading, hypoxya).
  • Methylmetacrylate embedding without decalcification of bone tissue. This can be done even on big specimens (section of femoral epiphysis) and also in presence of implants to assess one histomorphometry.
  • Preparation of thin and semithin sections by means of cutting and ablation techniques, as well as microtomes, specific staning, histomorphometric analysis on bidimensional histological section through a transmission optical microscope connected to a digital videocamera for taking the histological images.
  • Evaluation of bone structure parameters and of bone resorption. Correlation of these data with micro-CT data and micromechanics.
  • Histology of periprosthetic soft tissue - quantitative evaluation of wear.
  • Clinical trials mainly on medical devices.

Selected publications of the biological-and-clinical-research group:

  • Beraudi A, Catalani S, Montesi M, Stea S, Sudanese A, Apostoli P, Toni A. Detection of cobalt in synovial fluid from metal-on-metal hip prosthesis: correlation with the ion haematic level. Biomarkers. 2013 Dec;18(8):699-705.
  • De Pasquale D, Stea S, Squarzoni S, Bordini B, Amabile M, Catalani S, Apostoli P, Toni A. Metal-on-metal hip prostheses: correlation between debris in the synovial fluid and levels of cobalt and chromium ions in the bloodstream. Int Orthop. 2014 Mar;38(3):469-75.
  • Catalani S, Stea S, Beraudi A, Gilberti ME, Bordini B, Toni A, Apostoli P. Vanadium release in whole blood, serum and urine of patients implanted with a titanium alloy hip prosthesis. Clin Toxicol (Phila). 2013 Aug;51(7):550-6.
  • De Pasquale D, Stea S, Beraudi A, Montesi M, Squarzoni S, Toni A. Ceramic debris in hip prosthesis: correlation between synovial fluid and joint capsule. J Arthroplasty. 2013 May;28(5):838-41.
  • Stea S, Traina F, Beraudi A, Montesi M, Bordini B, Squarzoni S, Sudanese A, Toni A. Synovial fluid microanalysis allows early diagnosis of ceramic hip prosthesis damage. J Orthop Res. 2012 Aug;30(8):1312-20.
  • Beraudi A, Stea S, Bordini B, Baleani M, Viceconti M. Osteon classification in human fibular shaft by circularly polarized light. Cells Tissues Organs.2010;191(3):260-8.
  • Beraudi A, Stea S, Cremonini S, Visentin M, Toni A. Assessment of five interleukins in human synovial fluid as possible markers for aseptic loosening of hip arthroplasty. Artif Organs. 2009 Jul;33(7):538-43. Yearly report of the RIPO register, yearly available for download on the website https://ripo.cineca.it.
  • Bordini B, Stea S, Toni A. A different point of view on sex and risk of hip implant failure and failure rate in women. JAMA Intern Med. 2013 Sep 9;173(16):1557-8.
  • Stea S, Bordini B, Traina F, Toni A. Unexpected prevalence of arthritis in women's right hip. Artif Organs. 2011 Oct;35(10):972.
  • Traina F, De Fine M, Bordini B, Toni A. Risk factors for ceramic liner fracture after total hip arthroplasty. Hip Int. 2012 Nov-Dec;22(6):607-14.
  • Bordini B, Stea S, Cremonini S, Viceconti M, De Palma R, Toni A. Relationship between obesity and early failure of total knee prostheses. BMC Musculoskelet Disord. 2009 Mar 5;10:29.

Content edited by: Dr. Susanna Stea (stea@tecno.ior.it)

Content updated 25/06/2014 - 10:21
Content edited by: Redazione Web (redazioneweb@ior.it)
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