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OpenTrials
Completed

NCT Number: NCT06821581

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Healthcare expenses

    Time frame: 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.)

  2. Radiographic analysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: AL-TKA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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