Stability of the fixation in the bone
Conditions
Interventions
The study intervention is the fully cemented hinged-type revision TKA as used
in regular clinical practice.
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patient requires a revision total knee replacement and the Legion HK system is indicated in this patient. - Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form. - Patient plans to be available for follow-up through two years postoperative. - Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, haematological, or other conditions that would pose excessive operation risk.
Exclusion criteria
Exclusion criteria: - Patient has a BMI >40. - Patient has an active, local infection or systemic infection. - Patient is unable to come/return to the hospital or has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.). - Patient has an immunosuppressive disorder (chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients with acquired immunodeficiency syndrome (AIDS) or auto-immune diseases (including inflammatory arthritis). - Patient has a known sensitivity to materials in the device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the stability of the implant fixation in the bone at two years. Stability is measured and will be described by migration of the implant with regard to the (RSA markers in the) bone. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the functional performance of the Legion HK as revision TKA a set of Patient-Reported Outcome Measures (PROMs) as well as Clinician Reported Outcome Measures (CROMs) will be used. - Knee Society Score - Oxford Knee Score - KOOS-PS - VAS pain and VAS satisfaction - Adverse Events | — |
Countries
Netherlands
Outcome results
None listed