Patient-Specific 3D Guided Correction in High Tibial Osteotomy

Completed

• Conditions: Leg alignment correction; Osteotomy; 10028377; 10005944

• Registration Number: NL-OMON49330
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

- Medial overload as a result of a varus tibial deformity (MPTA <88 degrees) or
medial osteoarthrosis and an MPTA <90 degrees
- Age between 18 to 65 (male) or 60 (female) years
- Consenting to an osteotomy around the knee

Exclusion Criteria

- AP (anterior-posterior) instability as a result of ACL / PCL
(anterior/posterior cruciate ligaments) deficiency with an indication for
reconstruction
- Significant MCL (medial collateral ligament) instability (grade 3)
- Obesity (BMI > 35)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the number of outliers defined as > 3 degrees<br /><br>difference between planned and achieved correction angle in frontal plane from<br /><br>3D CT model. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints will be the difference between planned correction angle<br /><br>(frontal and sagittal) calculated from X-rays and from 3D CT modeling. And the<br /><br>sum of costs of 1 CT-scan, 3D planning and printing, additional surgical costs<br /><br>(sterilization unit) and operative times as recorded in the electronic patient<br /><br>record for using patient-specific cutting guides.</p><br>