Retrospective Eight Plate Study

August 12, 2020 updated by: AO Clinical Investigation and Publishing Documentation

A Retrospective Study to Assess the Outcome After Treatment With the Eight Plate System in Pediatric Patients

Understanding bone growth and achieving bone deformity corrections re-mains one of the oldest challenges in paediatric orthopaedics.

The purpose of this 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.

Study Overview

Status

Completed

Conditions

Detailed Description

One of the oldest mysteries in paediatric orthopaedics is the knowledge about bone growth and the ability to correct acquired bone deformities. Guiding the growth of a bone for deformity cor-rection by harnessing the ability of a growing bone to undergo plastic deformity is a well-known pediatric orthopaedic principle. Nevertheless, there are still many open questions concerning growth and guided growth. Several surgical options already exist for correction of angular de-formity and leg length discrepancies. The gold standard remains the corrective osteo¬tomy before or after growth arrest.

Correction during growth poses the risk of recurrence of the deformity during growth. By any means, growth modulation involves major surgery and requires internal or external fixation. Epiphysiodesis or hemiepiphysiodesis, either permanent or temporarily, can be done in an open or percutaneous way. Permanent epiphysiodesis is mainly performed using screws, while for a temporary epiphysiodesis staples or plate/screw systems are used. The treatment seems to be clinically effective, but the precise calculation of the remaining growth and the optimal surgical timing are crucial. Furthermore, the underlying biomechanical properties are not yet fully known.

The objective of this study is to investigate the clinical effects of the Eight Plate system for growth modulation treatments in pediatric patients undergoing leg length corrections or deformity corrections of the knee. The primary aim of the study is to assess outcome of growth modulation at removal of the implants with regards to AEs 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 Eight Plate removal. Furthermore, secondary aims include the investigation of the number and type of revision surgeries, any functional deficits after implant removal, any additional local AE, the assessment of the primary implant positioning, and any additional radiological parameters related to the implants and leg alignment.

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Karlsruhe, Germany, 76133
        • Kinderchirurgische Klinik Städtisches Klinikum Karlsruhe
      • Stuttgart, Germany, 70176
        • Klinikum Stuttgart
  • India
      • Pune, India
        • Sancheti Institute for Orthopaedics and Rehabilitation
  • Switzerland
      • Bern, Switzerland
        • Inselspital Bern
      • Genève, Switzerland, 1205
        • Hôpital Des Enfants
      • Zürich, Switzerland, 8032
        • Universitätskinderspital Zürich
  • United Kingdom
      • Stoke-on-Trent, United Kingdom, ST4 7QB
        • Guy Hilton Research Centre ISTM, Keele University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with an age range at implantation of the Eight Plate growth modulation devices of 18 months to 17 years

Treatment with Eight Plate (Orthofix) of varus/valgus deformities of the knee and/or leg length discrepancy due to any of the following:

  • Diseases or syndromes affecting the growth plate (eg, Blount's dis-ease)
  • Post-traumatic, affecting the growth plate
  • Post-infectious, affecting the growth plate
  • Idiopathic etiology

Description

Inclusion Criteria:

  • Age range at implantation of the Eight Plate growth modulation devic-es: 18 months to 17 years
  • Treatment with Eight Plate (Orthofix) of varus/valgus deformities of the knee and/or leg length discrepancy due to any of the following:
  • Diseases or syndromes affecting the growth plate (eg, Blount's dis-ease)
  • Post-traumatic, affecting the growth plate
  • Post-infectious, affecting the growth plate
  • Idiopathic etiology
  • Documented implantation of Eight Plate system(s) within the last 5 years
  • Documented explantation of all Eight Plate system(s)
  • Able to walk without walking aids prior to Eight Plate implantation

Exclusion Criteria:

  • Any tumor possibly influencing the growth plate(s) prior to last follow-up visit considered for this study
  • Cerebral palsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Growth modulation with Eight plate
Pediatric patients undergoing growth modulation with the Eight plate system

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Investigators

  • Principal Investigator: Theddy Slongo, MD, University Hospital Inselspital, Berne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 21, 2012

First Posted (ESTIMATE)

June 22, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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