Leg Length Discrepancy Clinical Trial
Official title:
A Retrospective Study to Assess the Outcome After Treatment With the Eight Plate System in Pediatric Patients
NCT number | NCT01625975 |
Other study ID # | 106309 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2012 |
Est. completion date | December 2013 |
Verified date | August 2020 |
Source | AO Innovation Translation Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 138 |
Est. completion date | December 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Months to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Kinderchirurgische Klinik Städtisches Klinikum Karlsruhe | Karlsruhe | |
Germany | Klinikum Stuttgart | Stuttgart | |
India | Sancheti Institute for Orthopaedics and Rehabilitation | Pune | |
Switzerland | Inselspital Bern | Bern | |
Switzerland | Hôpital des enfants | Genève | |
Switzerland | Universitätskinderspital Zürich | Zürich | |
United Kingdom | Guy Hilton Research Centre ISTM, Keele University | Stoke-on-Trent |
Lead Sponsor | Collaborator |
---|---|
AO Clinical Investigation and Publishing Documentation |
Germany, India, Switzerland, United Kingdom,
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---|---|---|---|
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