The primary objective of this study is to investigate the stability of the fixation in the bone of the Legion HK Hinge Knee System in revision TKA. The secondary objective of this study is to assess the functional performance/ effectiveness (…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
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-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
Background summary
As the number of primary total knee replacements increases annually, the need
for a good revision of a total knee arthroplasty (TKA) likewise will increase
exponentially. Hinged-type revision TKA systems are used with stems, the
prosthesis components are always cemented, whereas the stems can be placed
cemented or uncemented. Currently, the fully cemented (component placed
cemented, stems placed cemented) Legion HK system is used in the Sint
Maartenskliniek (SMK). Whether this construct in these patients results in
adequate stable and safe fixation of the implant in the bone, remains to be
investigated. World-wide this will be the first RSA study on a (fully cemented)
hinged-type revision TKA.
Study objective
The primary objective of this study is to investigate the stability of the
fixation in the bone of the Legion HK Hinge Knee System in revision TKA. The
secondary objective of this study is to assess the functional performance/
effectiveness (clinical results) of the Legion HK Revision Total Knee
Arthroplasty System.
Study design
The study will be a cohort study involving a total of twenty patients.
Participants will be assessed on 7 occasions (pre-op, operation/post-operative,
and at 6 weeks, 3 months, 6 months, 1 year and 2 years post-surgery). The
measurements at pre-operative, 6 months and 2 years do not coincide with
standard care visits. The study ends at 2 years follow-up.
Intervention
The study intervention is the fully cemented hinged-type revision TKA as used
in regular clinical practice.
Study burden and risks
The extra amount of time over the two years that a patient invests in the study
is about seven hours. There is no additional risk other than the regular risks
for a surgery of a revision TKA. The questionnaires and physical examinations
of the knee do not bring any extra burden and the additional radiological
assessments have a total amount of radiation that leads to a very small extra
risk.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58887.048.16 |
| OMON | NL-OMON29248 |