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In Vitro Microstructural and Mechanical Analysis of Waste Material From Total Knee Arthroplasty for the Study of Innovative Solutions in the Treatment of Joint and Ligament Pathologies (TIB PLAT)

30. april 2026 opdateret af: Stefano Zaffagnini

In orthopedic surgical practice, there is an increasing incidence of degenerative joint diseases, due to the rising average age of the population, as well as ligament injuries resulting from the growing participation in sports activities. The knee joint, in particular, is the most affected by these conditions, which, given their heterogeneous nature, impact patients across a wide age range.

Knee pathologies, often interconnected (with a higher incidence of degenerative diseases following ligamentous and/or meniscal injuries), are particularly debilitating for patients and entail high costs for the national healthcare system, which are expected to increase over time.

Scientific efforts in the field of knee surgery are therefore focused on achieving an increasingly detailed understanding of pathological conditions, as well as on the development of innovative technologies to support surgical and clinical practice.

Carrying out such analyses and developing new technologies inevitably involves experimental laboratory studies of joint tissues. The study of waste material obtained from surgical procedures represents a fundamental resource in this context and has always been used safely, with no additional invasiveness for the patient. A vast amount of information derived from laboratory analyses of discarded tissue has contributed to improving clinical practice and has led to the development of solutions that are now part of routine surgical use.

Recent technologies allow increasingly accurate evaluation of both the structure and mechanical properties of discarded tissue explanted during surgery. For example, structural assessment using micro-CT enables visualization and analysis of the interface between bone tissue, ligamentous structures, and surgical implants with micrometric precision. This makes it possible to determine tissue density, orientation, and material quality, distinguishing between different boundary conditions and physiopathological states of the tissues. Such analyses can also be performed under conditions close to those characterizing the joint in vivo, both in terms of tissue immersed in fluid and with respect to mechanical loads applied to deform the tissue. Furthermore, it is possible to reconstruct the structural interaction between human tissue and external materials used in surgery, such as screws, plates, anchoring devices, etc.

These instruments therefore make it possible to surpass the level of detail achievable with conventional diagnostic and research equipment used over the years, and to investigate with increasing accuracy the onset and progression of a pathology, the condition of the involved tissues, and to predict functional recovery of the treated site following the application of anchoring devices in the operating room. These new analyses also enable the study of innovative solutions for tissue repair and reconstruction, such as patient-specific customized devices and/or new materials produced using 3D printing technology, without posing any risk to the patient during surgery.

Studieoversigt

Status

Afsluttet

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

29

Kontakter og lokationer

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Studiesteder

      • Bologna, Italien, 40136
        • IRCCS Rizzoli Ortopedic Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Waste materials obtained from primary total knee arthroplasty procedures will be used. The collected material will mainly consist of osteochondral tissue from the patient's tibial plateau. This portion of tissue is routinely removed during the resection of the proximal (tibia) and distal (femur) bone components, which is necessary for the implantation of the prosthetic components. The resection and subsequent removal of the tibial plateau constitute a standard procedure and a mandatory step in primary total knee arthroplasty. This procedure will be performed intraoperatively by the medical staff of the coordinating investigator (Orthopaedic and Traumatology Clinic II). The waste material will be placed in a dedicated single-use container and transferred to the Research Center laboratories for analysis, in accordance with the above-mentioned internal procedure.

Beskrivelse

Inclusion Criteria:

  • Total knee arthroplasty
  • Kellgren-Lawrence grade II, III, or IV osteoarthritis;
  • age < 85 years;
  • BMI < 35

Exclusion Criteria:

  • History/evidence of previous partial (unicompartmental) knee arthroplasty;
  • positivity for viral infections such as HIV, HBV, or HCV;
  • inability to provide informed consent.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Microstructural properties of the explanted tissue
Tidsramme: At least 24 months
Porosity of the subchondral bone tissue
At least 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Load transfer mechanisms
Tidsramme: At least 24 months
Load transfer mechanisms from the residual cartilage tissue to the underlying bone tissue. Load transfer from the residual cartilage to the subchondral bone can be represented by the stress (Pa) developed in the underlying bone
At least 24 months
Bone/Tissue Density
Tidsramme: At least 24 months
Tissue density at the anterior cruciate ligament insertion will be quantified using micro-computed tomography and expressed as bone mineral density (mg HA/cm³).
At least 24 months
Structural Organization
Tidsramme: At least 24 months
Tissue orientation and homogeneity at the ligament insertion will be evaluated using histological and histomorphometric analysis and expressed using quantitative indices (e.g., orientation index, % area uniformity).
At least 24 months

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

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Studer store datoer

Studiestart (Faktiske)

30. november 2021

Primær færdiggørelse (Faktiske)

7. marts 2024

Studieafslutning (Faktiske)

7. januar 2025

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

30. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TIB PLAT

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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