NCT01625975

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

June 20, 2012

Last Update Submit

August 12, 2020

Conditions

Leg Length DiscrepancyVarus/Valgus Deformities of the Knee

Keywords

Growth modulationEight plateLeg length discrepancyVarus/valgus deformitiesPediatric

Study Arms (1)

Growth modulation with Eight plate

Pediatric patients undergoing growth modulation with the Eight plate system

Eligibility Criteria

Age18 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Kinderchirurgische Klinik Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Klinikum Stuttgart

Stuttgart, 70176, Germany

Location

Sancheti Institute for Orthopaedics and Rehabilitation

Pune, India

Location

Inselspital Bern

Bern, Switzerland

Location

Hôpital des enfants

Geneva, 1205, Switzerland

Location

Universitätskinderspital Zürich

Zurich, 8032, Switzerland

Location

Guy Hilton Research Centre ISTM, Keele University

Stoke-on-Trent, ST4 7QB, United Kingdom

Location

MeSH Terms

Conditions

Leg Length Inequality

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Theddy Slongo, MD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 22, 2012

Study Start

July 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

DE(2)CH(3)GB(1)IN(1)