The epidemiological evaluation and the post-marketing monitoring of orthopaedic medical devices are performed by RIPO (Register of Orthopaedic Prosthetic Implants), and REPO (Register of Orthopaedic Prosthetic Explants).
The Register of Orthopaedic Prosthetic Implants (R.I.P.O) was established at the Rizzoli Orthopaedic Institutes in 1990. All the 60 Orthopaedic Units in the Emilia-Romagna region (approx. 4 millions inhabitants) joined it from January 2000.
By December 31st, 2018 the Register collected data of nearly:
- 125.000 total hip-replacement (18.000 hip revisions and 45.000 hemiarthoplasties);
- 100.000 knee replacements (8.000 knee revisions);
- 6.000 shoulder replacements.
More than 95% of surgeries performed in the Emilia-Romagna region are reported to RIPO, ensuring the reliability of the data analysis.
The collected variables are: side of surgery, reasons for revision hip, knee and shoulder prosthesis surgery, surgical procedure, complications during hospitalization, commercial type, reference code, and batch number of each single implanted component.
The end-point is the revision of even a single component of the prosthesis.
More than 100 different types of commercial hip prostheses and 80 knee prostheses are monitored to evaluate their outcomes.
The register co-operates with the orthopaedic surgeons and the regional authorities to define observational studies and to 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 early failure based on recalls made by the Ministry of Health or manufacturers can thus be identified. At this point, orthopaedic surgeons may be in the position to promptly adopt all the necessary measures to defend the health of the patient.
The Register is 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 of the collection, classification, and analysis of medical devices explanted at the Rizzoli Orthopaedic Institute, in order to conduct post-marketing monitoring studies on these devices.
During 18 years of activity, more than 4.000 devices have been collected, mostly hip and knee prostheses. Devices involved in reported accidents are available to legal authorities, manufacturers and patients according to the internal procedure.
Selected publications of the biological-and-clinical-research group:
- Bordini B, Stea S, Castagnini F, Busanelli L, Giardina F, Toni A. The influence of bearing surfaces on periprosthetic hip infections: analysis of thirty nine thousand, two hundred and six cementless total hip arthroplasties. Int Orthop. 2019 Jan;43(1):103-109. doi: 10.1007/s00264-018-4097-2. Epub 2018 Aug 11. PubMed PMID: 30099642
- Giardina F, Castagnini F, Stea S, Bordini B, Montalti M, Toni A. Short Stems Versus Conventional Stems in Cementless Total Hip Arthroplasty: A Long-Term Registry Study. J Arthroplasty. 2018 Jan 11. pii: S0883-5403(18)30013-5. doi:10.1016/j.arth.2018.01.005. [Epub ahead of print] PubMed PMID: 29395723
- Porcellini G, Combi A, Merolla G, Bordini B, Stea S, Zanoli G, Paladini P. The experience of the RIPO, a shoulder prosthesis registry with 6-year follow-up. Musculoskelet Surg. 2017 Dec 4. doi: 10.1007/s12306-017-0529-1. [Epub ahead of print] PubMed PMID: 29204822
- Boyer B, Bordini B, Caputo D, Neri T, Stea S, Toni A. Is Cross-Linked Polyethylene an Improvement Over Conventional Ultra-High Molecular Weight Polyethylene in Total Knee Arthroplasty? J Arthroplasty. 2018 Mar;33(3):908-914. doi: 10.1016/j.arth.2017.10.005. Epub 2017 Oct 10. PubMed PMID: 29089224
- Castagnini F, Sudanese A, Bordini B, Tassinari E, Stea S, Toni A. Total Knee Replacement in Young Patients: Survival and Causes of Revision in a Registry Population. J Arthroplasty. 2017 Nov;32(11):3368-3372. doi: 10.1016/j.arth.2017.05.052. Epub 2017 Jun 8. PubMed PMID: 28655567.