Aseptic LooseningAL-TKANCT06821581
Economic-demographic Assessment of the Aseptic Mobilization of Knee Prostheses Through the RIPO Registry and Radiographic Analysis of the Case Series From the II Clinic of IOR
An observational study of Aseptic Loosening and Arthropathy of Knee, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The increase in life expectancy is leading to an increase in the average age of patients undergoing total knee arthroplasty (TKA), and, consequently, an increase in the number of revisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aseptic Loosening, Arthropathy of Knee
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jan 2026to 7 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The analysis will be conducted on implants performed in the Emilia-Romagna region from 2003 to 2022 and on implants performed at the II Orthopedic and Traumatological Clinic of the Rizzoli Orthopedic Institute during the same period
Who may be able to join
- Patients undergoing knee prosthesis revision for aseptic mobilization
- Follow-up ≥ 2 years
- Willingness to participate in the study
- Both sexes
- Patients ≥ 18 years old
Who cannot join
- Patient refusal to participate in the study and sign the informed consent
- Simultaneous participation in other studies
Trial locations and contacts
1 site in 1 country.
About this study
The increase in life expectancy is leading to an increase in the average age of patients undergoing total knee arthroplasty (TKA), and, consequently, an increase in the number of revisions. The main cause of TKA failure is aseptic mobilization, which is described as the loss of integration between the prosthetic component and the bone in the absence of infection. This represents a significant impact on professional and economic resources for the Italian healthcare system. Aseptic mobilization can be caused by inadequate initial fixation of the implant and/or mechanical or biological loss of fixation over time, factors that often occur simultaneously. A careful, methodical evaluation of post-operative radiographs of TKAs remains an important diagnostic tool. The analysis of the causes of aseptic mobilization of TKAs and the associated economic impact in the Emilia Romagna region is useful for providing an estimate of the problem and identifying potential areas for improvement.
- Conditions
- Aseptic Loosening, Arthropathy of Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
Collection of registry data related to the sample of patients undergoing TKA revision for aseptic mobilization, including demographic data
Measured: 24 months
Secondary outcomes (2)
Healthcare expenses
Collection of data related to healthcare expenses resulting from aseptic mobilization (TKA revision surgery, length of stay, 90-day readmission rate, any other hospitalizations, etc.)
Measured: 24 months
Radiographic analysis
Radiographic analysis of the TKAs of patients who subsequently underwent revision surgery for aseptic mobilization at the II Orthopedic and Traumatological Clinic to assess the implant
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start13 Jan 2026
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aseptic LooseningStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Zaffagnini, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821581
- Sponsor's protocol ID
- AL-TKA
- Acronym
- AL-TKA
- Status last verified
- Jun 2026
- First submitted
- 6 Feb 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic-demographic Assessment of the Aseptic Mobilization of Knee Prostheses Through the RIPO Registry and Radiographic Analysis of the Case Series From the II Clinic of IOR
- ClinicalTrials.gov ID
- NCT06821581
- Acronym / sponsor ID
- AL-TKA / AL-TKA
- Conditions
- Aseptic Loosening, Arthropathy of Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 12 Feb 2025 (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.
The increase in life expectancy is leading to an increase in the average age of patients undergoing total knee arthroplasty (TKA), and, consequently, an increase in the number of revisions. The main cause of TKA failure is aseptic mobilization, which is described as the loss of integration between the prosthetic component and the bone in the absence of infection. This represents a significant impact on professional and economic resources for the Italian healthcare system. Aseptic mobilization can be caused by inadequate initial fixation of the implant and/or mechanical or biological loss of fixation over time, factors that often occur simultaneously. A careful, methodical evaluation of post-operative radiographs of TKAs remains an important diagnostic tool. The analysis of the causes of aseptic mobilization of TKAs and the associated economic impact in the Emilia Romagna region is useful for providing an estimate of the problem and identifying potential areas for improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The analysis will be conducted on implants performed in the Emilia-Romagna region from 2003 to 2022 and on implants performed at the II Orthopedic and Traumatological Clinic of the Rizzoli Orthopedic Institute during the same period
Key inclusion criteria (5 listed)
- Patients undergoing knee prosthesis revision for aseptic mobilization
- Follow-up ≥ 2 years
- Willingness to participate in the study
- Both sexes
- Patients ≥ 18 years old
Key exclusion criteria (2 listed)
- Patient refusal to participate in the study and sign the informed consent
- Simultaneous participation in other studies
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
Demographic data
Time frame: 24 months
Collection of registry data related to the sample of patients undergoing TKA revision for aseptic mobilization, including demographic data
2 secondary outcomes
Healthcare expenses
Time frame: 24 months
Radiographic analysis
Time frame: 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 18 Jun 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 Aseptic Loosening and Arthropathy of Knee, run by Istituto Ortopedico Rizzoli 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 5 inclusion and 2 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 18 Jun 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?
Demographic data (time frame: 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 18 Jun 2026.