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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06821581
Acronym
AL-TKA
Enrollment
31
Registered
2025-02-12
Start date
2026-01-13
Completion date
2026-05-07
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee, Aseptic Loosening

Brief 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. 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.

Interventions

None listed

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing knee prosthesis revision for aseptic mobilization * Follow-up ≥ 2 years * Willingness to participate in the study * Both sexes * Patients ≥ 18 years old

Exclusion criteria

* Patient refusal to participate in the study and sign the informed consent * Simultaneous participation in other studies

Design outcomes

Primary

MeasureTime frameDescription
Demographic data24 monthsCollection of registry data related to the sample of patients undergoing TKA revision for aseptic mobilization, including demographic data

Secondary

MeasureTime frameDescription
Healthcare expenses24 monthsCollection of data related to healthcare expenses resulting from aseptic mobilization (TKA revision surgery, length of stay, 90-day readmission rate, any other hospitalizations, etc.)
Radiographic analysis24 monthsRadiographic 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026