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The FDR (Femoral Derotaton) Trail.

NCT04086368 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-11-03

No results posted yet for this study

Summary

Femoral derotational osteotomy is the gold standard to correct symptomatic patients with increased femoral AV. There is no clear evidence in the literature supporting which surgical technique or implant that should be used. Traditionally these patients are treated with an open osteotomy and plate and screw fixation. In recent years intramedullary nailing with adolescent interlocking nail has been described and has shown to be a safe method. Percutaneous osteotomy and intramedullary nailing is considered a less invasive technique compared with open osteotomy and plate and screw fixation.

The primary objective of this project, is to investigate if derotational osteotomy by means of percutaneous osteotomy and nailing is a safe and accurate method compared to an open approach and plating.

Conditions

  • Idiopathic Increased Femoral Anteversion

Interventions

DEVICE

Adolescent Lateral Entry Femoral Nail

The use of an less invasive implant that has the same accuracy.

DEVICE

Pediatric LCP Hip Plate System

Open approach to the femur where the osteotomy and osteofixation with plate and screws are preformed

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Anders Grønseth, M.D · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2025-06-15
Completion
2031-06-15

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04086368 on ClinicalTrials.gov