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.
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.
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.
- Conditions
- Knee Injuries, Prosthesis User
- Medical subject headings
- Knee Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Microstructural properties of the explanted tissue
Porosity of the subchondral bone tissue
Measured: At least 24 months
Secondary outcomes (3)
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
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
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.
- First posted6 May 2026
- Study start30 Nov 2021
- Primary completion7 Mar 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Stefano Zaffagnini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07571512
- Acronym / sponsor ID
- TIB PLAT / TIB PLAT
- Conditions
- Knee Injuries, Prosthesis User
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Stefano ZaffagniniUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- Total knee arthroplasty
- Kellgren-Lawrence grade II, III, or IV osteoarthritis;
- age < 85 years;
- BMI < 35
Key exclusion criteria (3 listed)
- History/evidence of previous partial (unicompartmental) knee arthroplasty;
- positivity for viral infections such as HIV, HBV, or HCV;
- inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microstructural properties of the explanted tissue
Time frame: At least 24 months
Porosity of the subchondral bone tissue
3 secondary outcomes
Load transfer mechanisms
Time frame: At least 24 months
Bone/Tissue Density
Time frame: At least 24 months
Structural Organization
Time frame: At least 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.