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)

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.

Study Overview

• Status: Completed
• Conditions: Knee Injuries; Prosthesis User

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • IRCCS Rizzoli Ortopedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microstructural properties of the explanted tissue	Porosity of the subchondral bone tissue	At least 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Load transfer mechanisms	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	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	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

Collaborators and Investigators

• Sponsor: Stefano Zaffagnini

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): March 7, 2024
• Study Completion (Actual): January 7, 2025

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: TIB PLAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No