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Primary stability of fully cemented LEGION HK Hinge Knee System in revision total knee arthroplasty measured with RSA


- candidate number26738
- NTR NumberNTR6410
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-feb-2017
- Secondary IDsNL58887.048.16 METC
- Public TitlePrimary stability of fully cemented LEGION HK Hinge Knee System in revision total knee arthroplasty measured with RSA
- Scientific TitlePrimary stability of fully cemented LEGION HK Hinge Knee System in revision total knee arthroplasty measured with RSA
- ACRONYMLegion Hinged RSA
- hypothesis
- Healt Condition(s) or Problem(s) studiedKnee arthroplasty, Radio Stereometric Analysis, Cemented fixation
- 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 operative risk.
- Exclusion criteria• Patient has a BMI >35.
• Patient has an active, local infection or systemic infection.
• Patient with a prosthetic joint infection as indication for a total knee revision
• 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2017
- planned closingdate31-dec-2019
- Target number of participants20
- InterventionsParticipants will receive the Legion HK Revision Total Knee Arthroplasty System which is commercially available and has a CE mark (Legion HK System, Smith & Nephew Ltd).
- Primary outcomeThe 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 outcomeTo assess the functional performance of the Legion HK as revision TKA a set of Patient-Rported 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
- Timepoints- Pre-operative
- Post-operative
- after 6 weeks
- after 3 months
- after 6 months
- after 12 months
- after 24 months
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Malou E.M. te Molder
- CONTACT for SCIENTIFIC QUERIES Malou E.M. te Molder
- Sponsor/Initiator Sint Maartenskliniek Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Smith & Nephew
- Publicationsn/a
- Brief summaryParticipants will receive the Legion HK Revision Total Knee Arthroplasty System which is commercially available and has a CE mark (Legion HK System, Smith & Nephew Ltd).

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 outcomes:
To assess the functional performance of the Legion HK as revision TKA a set of Patient-Rported 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
- Main changes (audit trail)
- RECORD21-feb-2017 - 19-jul-2017


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