Leg Length DiscrepancyNCT01625975
Retrospective Eight Plate Study
An observational study of Leg Length Discrepancy and Varus/Valgus Deformities of the Knee, run by AO Clinical Investigation and Publishing Documentation at 7 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 months to 17 years
- Conditions the study is for
- Leg Length Discrepancy, Varus/Valgus Deformities of the Knee
- How many people
- 138 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jul 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Any tumor possibly influencing the growth plate(s) prior to last follow-up visit considered for this study
- Cerebral palsy
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Switzerland3 sites
Inselspital Bern
Bern
Hôpital des enfants
Geneva, 1205
Universitätskinderspital Zürich
Zurich, 8032
Germany2 sites
Kinderchirurgische Klinik Städtisches Klinikum Karlsruhe
Karlsruhe, 76133
Klinikum Stuttgart
Stuttgart, 70176
United Kingdom1 site
Guy Hilton Research Centre ISTM, Keele University
Stoke-on-Trent, ST4 7QB
About this study
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.
Read the 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.
- Keywords
- Growth modulation, Eight plate, Leg length discrepancy, Varus/valgus deformities, Pediatric
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Growth modulation with Eight plate | Pediatric patients undergoing growth modulation with the Eight plate system |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Length DiscrepancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theddy Slongo, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625975
- Sponsor's protocol ID
- 106309
- Status last verified
- Aug 2020
- First submitted
- 20 Jun 2012
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Assess the Outcome After Treatment With the Eight Plate System in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01625975
- Acronym / sponsor ID
- 106309
- Keywords
- Growth modulation, Eight plate, Leg length discrepancy, Varus/valgus deformities, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Growth modulation with Eight plate | – | –Pediatric patients undergoing growth modulation with the Eight plate system |
Who may qualify
- Ages
- 18 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Any tumor possibly influencing the growth plate(s) prior to last follow-up visit considered for this study
- Cerebral palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
Related trials for Leg Length Discrepancy
Enrolling by invitation
Ultrasound Use to Measure Magnetically Controlled Growing Rods
Limb Length Discrepancy
Not yet recruiting
Acute Effect of Standardized Ankle Taping on Lower Limb Asymmetry During Countermovement Jump in Healthy Judokas
Ankle Stability
RecruitingObservational study
Analysis of the Biomechanical Impact of Lower Limb Length Inequality in PEDiatrics
Lower Limb Length Discrepancy (LLD) in Children
RecruitingObservational study
Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Leg Length Inequality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theddy Slongo, MD principal investigator
Insel Gruppe AG, University Hospital Bern
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leg Length Discrepancy and Varus/Valgus Deformities of the Knee, run by AO Clinical Investigation and Publishing Documentation at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland, Germany, India, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.