Derotational Femoral Osteotomy With Either Percutaneous Osteotomy and Intramedullary Nailing or Open Approach and Plating - a Randomized Controlled Trail

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: t
View:

• Radiographic findings: Femoral AV angle ≥ 30°

• Age 10-18 years.

• Hip or/and knee pain

• Less than 15 degrees external rotation of the hips

Locations
Other Locations
Norway
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Anders Grønseth, M.D
andgro@ous-hf.no
004791320205
Backup
Joachim Horn, M.D PhD
jhorn@ous-hf.no
Time Frame
Start Date: 2019-10-22
Estimated Completion Date: 2031-06-15
Participants
Target number of participants: 42
Treatments
Active_comparator: The Synthes Pediatric LCP Plate System
Open osteotomy and osteofixation with the pediatric LCP hip plate
Experimental: The adolescent Lateral Femoral Nail
Percutaneous osteotomy and intramedullary nailing
Related Therapeutic Areas
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov