Relation between femoral Component Rotation And Clinical outcomes in total Knee replacement (CRACK). A prospective observational study

Recruiting

• Conditions: 10005944; knee replacement; Total knee prosthesis; 10023213

• Registration Number: NL-OMON55865
• Lead Sponsor: Deventer Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Knee osteoarthritis;
- Informed consent for the surgical procedure;
- Signed informed consent for the study.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Contra-indication for joint replacement surgery in general (pregnancy, active
infection, severe cardiac and respiratory comorbidities);
- Previous distal femoral or proximal tibial fracture resulting in an altered
anatomy;
- Previous osteotomies around the knee resulting in altered anatomy.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of this study are (1) the change from baseline PROMs at<br /><br>1-year follow-up, and (2) the degree of femoral, tibial and combined component<br /><br>rotation.<br /><br>The following PROMs will be used:<br /><br>- Oxford Knee Score (OKS);<br /><br>- Knee Injury and Osteoarthritis Outcome Score (KOOS);<br /><br>- EQ-5D;<br /><br>- VAS pain.<br /><br>In addition, we will use the clinician-administered American Knee Society Score<br /><br>(AKSS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the range of motion, and early revision because of<br /><br>malposition.</p><br>