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

NCT06821581 | Recruiting DMC

• 1 other identifier: AL-TKA
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Aseptic Loosening; Arthropathy of Knee

Outcome Measures

Primary Outcomes (1)

• Demographic data

  Collection of registry data related to the sample of patients undergoing TKA revision for aseptic mobilization, including demographic data

  24 months

Secondary Outcomes (2)

• Healthcare expenses

  24 months

• Radiographic analysis

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Medicine and Surgery, University of Bologna

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-02

Locations

IT (1)