Leg Length Discrepancy Clinical Trial
Official title:
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.
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.
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