Construct stability with the use of cones in revision total knee arthroplasty measured with RSA

Recruiting

Conditions: degenerative joint disease
knee osteoarthritis
10005944

Registration Number: NL-OMON52619

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study is the stability of the revision construct<br /><br>with cones at two and five years. Stability is measured and will be described<br /><br>by migration of the implant with regard to the (RSA markers in the) bone.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secundary endpoint is the survival of the revised TKA system. Additionally,<br /><br>clinical and functional performance will be evaluated.</p><br>