DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Feb 17, 2025

Keywords

ClinConnect Summary

The DIGITAL-KNEE Study is researching a new system called the AtMoves Knee System to help doctors better diagnose a problem known as aseptic loosening in patients who have had knee replacement surgery. Aseptic loosening occurs when the knee joint becomes unstable without an infection being present, which can lead to pain and difficulty moving. The study aims to find out whether using the AtMoves system helps reduce the number of patients who have poor outcomes after one year, as measured by a specific score that assesses knee function and quality of life.

To participate in this study, individuals must be at least 18 years old and have undergone knee replacement surgery. They should also be experiencing symptoms that make their doctor suspect aseptic loosening, but where the diagnosis isn't clear after initial examinations and regular X-rays. Participants will be divided into two groups: one will receive an additional CT scan with the AtMoves system, while the other will not, although both groups can have other tests if needed. Over the course of a year, participants will fill out questionnaires to help researchers track their progress and any changes in their knee health. This study is currently recruiting participants, and it includes people of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 years or older.
• • Subjects must have underwent either unilateral or bilateral TKA surgery.
• • Aseptic loosening is one of the differential diagnoses of the treating orthopaedic surgeon
• • The treating Orthopaedic Surgeon is uncertain of the diagnosis after anamnesis, physical examination and conventional x-ray.
• • The surgeon wants additional examinations or additional imaging to arrive at the diagnosis and proposal for treatment.
• • Subjects must be capable of giving informed consent and must be willing to undergo examination with the AtMoves Knee System.
• Exclusion Criteria:
• • A clear other cause for complaints other than aseptic loosening (e.g. septic loosening, neuropathic pain, non-consolidated peri-prosthetic fracture of the bone around the TKA)
• • Surgical interventions of the index knee in the year prior to the start of the complaints associated with TKA loosening.
• • Posttraumatic or congenital deformation of the leg for which the loading device does not fit.
• • Pregnancy or suspected pregnancy.
• • Unable or unwilling to understand or sign the informed consent for this study and to undergo examination with the AtMoves Knee System.