PediLoc® Blade Plate in Distal Femoral Osteotomies

NCT ID: NCT06950047

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-28

Study Completion Date

2025-04-14

Brief Summary

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Background: The PediLoc® Locking Cannulated Blade Plate System, originally designed for proximal femoral osteotomies, has also been used for multidimensional deformity correction of the distal femur. This study describes the surgical technique and retrospectively analyses consolidation rates of distal femoral osteotomies using this system, comparing them to distal femoral osteotomies using the DePuy Synthes® 90°LCP Pediatric Condylar Plate.

Materials and methods: A retrospective review was conducted for patients who underwent distal femoral osteotomy with the PediLoc® Blade Plate (Blade Plate) and the DePuy Synthes® 90°LCP Pediatric Condylar Plate (90°LCP-PCP) at the University Children's Hospital Zurich (2020-2024). Consolidation rates were assessed using Reborn-, Rust-, and modified Rust-scores at 6 weeks, 3 months, and 6 months postoperatively and compared using an unpaired t-test. Geometric planes of osteotomy were analysed, and a stepwise correction technique was described.

Detailed Description

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Conditions

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Osteotomy of Lower Extremity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System

distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System

Intervention Type PROCEDURE

distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System

distal femoral osteotomies using the 90°LCP-PCP

distal femoral osteotomies using the 90°LCP-PCP

Intervention Type PROCEDURE

distal femoral osteotomies using the 90°LCP-PCP

Interventions

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distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System

distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System

Intervention Type PROCEDURE

distal femoral osteotomies using the 90°LCP-PCP

distal femoral osteotomies using the 90°LCP-PCP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All Patients that underwent distal femoral osteotomies
* informed consent

Exclusion Criteria

* intraoperative technical error
* missing data
* missing IC
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Samuel Tschudi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Children's Hospital Zürich

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2025-0000

Identifier Type: -

Identifier Source: org_study_id

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