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OpenTrials
Completed

NCT Number: NCT06950047

PediLoc® Blade Plate in Distal Femoral Osteotomies

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.

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Key information

Conditions

Osteotomy of Lower Extremity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zürich

Zurich, Canton of Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All Patients that underwent distal femoral osteotomies
  • informed consent

Exclusion criteria

  • intraoperative technical error
  • missing data
  • missing IC

Treatment and study plan

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 90°LCP-PCP

Procedure

distal femoral osteotomies using the 90°LCP-PCP

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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