PediLoc® Blade Plate in Distal Femoral Osteotomies

April 29, 2025 updated by: Samuel Tschudi, University Children's Hospital, Zurich

Application of PediLoc®Locking Cannulated Blade Plate System in Distal Femoral Osteotomies - A Retrospective, Comparative Analysis of Consolidation Rates and Description of the Surgical Technique

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8008
        • University Children's Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This retrospective study investigated the electronic medical records of patients who underwent distal femoral osteotomy with the Blade Plate system and the 90°LCP-PCP at the University Children's Hospital Zurich between 2020 and 2024.

Description

Inclusion Criteria:

  • All Patients that underwent distal femoral osteotomies
  • informed consent

Exclusion Criteria:

  • intraoperative technical error
  • missing data
  • missing IC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System
Procedure: distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System
distal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System
distal femoral osteotomies using the 90°LCP-PCP
Procedure: distal femoral osteotomies using the 90°LCP-PCP
distal femoral osteotomies using the 90°LCP-PCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consolidation rates using Reborn-, Rust- and modified Rust-scores on serial X-ray images
Time Frame: 6 weeks, 3 months, 6 months
Reborn Score: Minimum: 4pts. maximum 16pts., higher scores are better Rust Score ( Radiographic Union Scale for the Tibia ): Minimum: 4pts. maximum 12pts., higher scores are better modified Rust Score ( Radiographic Union Scale for the Tibia ): Minimum: 4pts. maximum 16pts., higher scores are better
6 weeks, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2025

Primary Completion (Actual)

April 14, 2025

Study Completion (Actual)

April 14, 2025

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-0000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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