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CompletedNCT06950047Updated May 2, 2025

PediLoc® Blade Plate in Distal Femoral Osteotomies

An observational study in Osteotomy of Lower Extremity, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by University Children's Hospital, Zurich · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
111
Sex
All
01

Study 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.

02

Conditions studied

  • Osteotomy of Lower Extremity

Keywords

  • locking plate system
  • blade plate
  • distal femoral osteotomy
  • flexion contracture
  • deformities
  • multidimensional osteotomies
  • pediatric orthopedics
  • surgical technique
03

In context

Lead sponsor

University Children's Hospital, Zurich is the lead sponsor of 92 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Inclusion criteria

  • All Patients that underwent distal femoral osteotomies
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • intraoperative technical error
  • missing data
  • missing IC
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
111 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Proceduredistal femoral osteotomies using the PediLoc® Locking Cannulated Blade Plate System

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

  • Proceduredistal femoral osteotomies using the 90°LCP-PCP

    distal femoral osteotomies using the 90°LCP-PCP

06

What researchers measure

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

    Time frame: 6 weeks, 3 months, 6 months

07

Study locations

1 site
  • University Children's Hospital Zürich
    Zürich, 8008, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06950047
Lead sponsor
University Children's Hospital, Zurich
Responsible party
Samuel Tschudi (Principal Investigator, University Children's Hospital, Zurich) — Principal investigator
First posted
Apr 29, 2025
Start date
Mar 28, 2025
Primary completion
Apr 14, 2025
Completion
Apr 14, 2025
Last update
May 2, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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