No registrations found.
ID
Source
Brief title
Health condition
revisie totale knie arthroplastiek
volledig gecementeerde fixatie
radiostereometrische analyse
revision total knee arthroplasty
fully cemented fixation
radiostereometric analysis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Participants 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
Study design
- Pre-operative
- Post-operative
- after 6 weeks
- after 3 months
- after 6 months
- after 12 months
- after 24 months
Intervention
Participants 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).
Sint Maartenskliniek Nijmegen Postbus 9011
Nijmegen 6500 GM
The Netherlands
+31 (0)24 3659073
m.temolder@maartenskliniek.nl
Sint Maartenskliniek Nijmegen Postbus 9011
Nijmegen 6500 GM
The Netherlands
+31 (0)24 3659073
m.temolder@maartenskliniek.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6230 |
| NTR-old | NTR6410 |
| CCMO | NL58887.048.16 |
| OMON | NL-OMON45618 |