Eight Plate Study
Research type
Research Study
Full title
A Retrospective Study to Assess the Outcome After Treatment With the Eight Plate System in Pediatric Patients
IRAS ID
117854
Contact name
Jonathan Dwyer
Contact email
Sponsor organisation
AO Foundation
Clinicaltrials.gov Identifier
Research summary
Understanding bone growth and achieving bone deformity corrections remains one of the oldest challenges in paediatric orthopaedics.
The purpose of this retrospective study is to investigate the clinical and biomechanical effects of implants for growth modulation in pediatric patients undergoing correction of leg length or deformities of the knee.
The primary aim of the study is to assess outcome after growth modulation using the Eight plate (Orthofix) at the time of implant removal with regard to any Adverse Events (AE) related to the growth plates or implants under investigation. The secondary aims are to assess if the planned correction was achieved and if the achieved correction was maintained after implant removal. Furthermore, secondary aims include investigation of the number and type of revision surgeries, the proportions of any other local AE as well as any influencing factors for growth modulation.REC name
London - Queen Square Research Ethics Committee
REC reference
13/LO/0892
Date of REC Opinion
6 Jun 2013
REC opinion
Favourable Opinion