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Knee InjuriesTIB PLATNCT07571512

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

An observational study of Knee Injuries and Prosthesis User, run by Stefano Zaffagnini at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Knee Injuries, Prosthesis User
How many people
29 participants
Where
1 siteItaly
Study dates
30 Nov 2021to 7 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Rizzoli Ortopedic Institute

    Bologna, 40136

Other trials in Italy

About this study

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.

Read more

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.

Medical subject headings
Knee Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microstructural properties of the explanted tissue

    Porosity of the subchondral bone tissue

    Measured: At least 24 months

Secondary outcomes (3)
  1. 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

    Measured: At least 24 months

  2. 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).

    Measured: At least 24 months

  3. 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).

    Measured: At least 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study start30 Nov 2021
  3. Primary completion7 Mar 2024
  4. Study completion7 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07571512
Sponsor's protocol ID
TIB PLAT
Acronym
TIB PLAT
Status last verified
Apr 2026
First submitted
21 Apr 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Injuries and Prosthesis User, run by Stefano Zaffagnini at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microstructural properties of the explanted tissue (time frame: At least 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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