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 (AL-TKA)

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 Overview

• Status: Completed
• Conditions: Arthropathy of Knee; Aseptic Loosening

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40136
      • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	Collection of registry data related to the sample of patients undergoing TKA revision for aseptic mobilization, including demographic data	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	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	24 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Actual): May 7, 2026
• Study Completion (Actual): May 7, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: AL-TKA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No