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Patient-Specific 3D Guided Correction in High Tibial Osteotomy

Patient-Specific 3D Guided Correction in High Tibial Osteotomy - 3D Guided HTO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49330
Enrollment
56
Registered
2020-07-20
Start date
2021-01-05
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leg alignment correction Osteotomy

Interventions

In the intervention group a patient-specific cutting guide will be used to assist positioning and angle of the saw cut, and provide guidance on the degree of angular correction from the pre-operativ

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Medial overload as a result of a varus tibial deformity (MPTA

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the number of outliers defined as > 3 degrees difference between planned and achieved correction angle in frontal plane from 3D CT model.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)