The primary objective of this study is to investigate the stability of the fixation in the bone of the use of the Legion prosthesis with cones in revision TKA, until 5 years postoperatively. The secondary objective of this study is to assess the…
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 this study is the stability of the revision construct
with cones at two and five years. Stability is measured and will be described
by migration of the implant with regard to the (RSA markers in the) bone.
Secondary outcome
The secundary endpoint is the survival of the revised TKA system. Additionally,
clinical and functional performance will be evaluated.
Background summary
In (re-)revision total knee arthroplasty (TKA), cones can be used to ensure
sufficient fixation of the revision construct in the bone in cases with
suboptimal metaphyseal bone stock. Together with press-fit placed stems of
sufficient length cones can reduce interface stresses of damaged bone in the
distal femur or proximal tibia and provide additional prosthetic surface for
implant fixation. Whether this construct in revision cases results in adequate
stable and safe fixation of the implant in the bone, remains to be
investigated. With radiostereometric analysis (RSA) it is possible to
investigate the stability of the construct in a very accurate way.
Study objective
The primary objective of this study is to investigate the stability of the
fixation in the bone of the use of the Legion prosthesis with cones in revision
TKA, until 5 years postoperatively. The secondary objective of this study is to
assess the survival of the Legion revision TKA with cones.
Study design
Prospective cohort study.
Intervention
The study intervention is the hybrid fixation of Legion revision TKA with cones
as used in regular clinical practice.
Study burden and risks
The extra amount of time over the five 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. The additional
radiological assessments have a total amount of 24 µSv radiation, which is a
neglectable extra risk considering the background radiation of 2 mSv per year
in the Netherlands.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
• Patients requiring a (re-(re-))revision of their total knee arthroplasty and
the Legion system with the use of a cone in the tibia because of metaphyseal
bone loss.
• Patient is willing to consent to participate in the study.
• Patient is <78 years old
• Patient plans to be available for follow-up through five years post-operative.
• 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 ( < ASA II).
Exclusion criteria
• Indication for a hinged-type revision system.
• Active, local infection or systemic infection.
• Patient has physical, emotional, or neurological conditions that would
compromise the patient*s compliance with postoperative rehabilitation and
follow-up.
• Patient has an immunosuppressive disorder (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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66833.091.18 |