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

Recruiting

• Conditions: Aseptic Loosening; Arthropathy of Knee

• Registration Number: NCT06821581
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Study Start: 2025-05
• Primary Completion: 2025-10
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic data	24 months	Collection of registry data related to the sample of patients undergoing TKA revision for aseptic mobilization, including demographic data

Secondary Outcome Measures

Name	Time	Method
Healthcare expenses	24 months	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.)
Radiographic analysis	24 months	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

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy