PediLoc® Blade Plate in Distal Femoral Osteotomies

NCT06950047 | Completed

• 1 other identifier: 2025-0000
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteotomy of Lower Extremity

Keywords

locking plate system; blade plate; distal femoral osteotomy; flexion contracture; deformities; multidimensional osteotomies; pediatric orthopedics; surgical technique

Outcome Measures

Primary Outcomes (1)

• Consolidation rates using Reborn-, Rust- and modified Rust-scores on serial X-ray images

  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

Study Arms (2)

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

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All Patients that underwent distal femoral osteotomies
• informed consent

You may not qualify if:

• intraoperative technical error
• missing data
• missing IC

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zürich

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 29, 2025
• Study Start: March 28, 2025
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)