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Retrospective Eight Plate Study

NCT01625975 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2020-08-14

No results posted yet for this study

Summary

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.

Conditions

  • Leg Length Discrepancy
  • Varus/Valgus Deformities of the Knee

Sponsors & Collaborators

  • AO Clinical Investigation and Publishing Documentation

    lead OTHER

Principal Investigators

  • Theddy Slongo, MD · Insel Gruppe AG, University Hospital Bern

Eligibility

Min Age
18 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • Germany
  • India
  • Switzerland
  • United Kingdom

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 NCT01625975 on ClinicalTrials.gov