Retrospective Eight Plate Study
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| First Received Date ICMJE | June 20, 2012 | ||||||||
| Last Updated Date | February 26, 2013 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01625975 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Retrospective Eight Plate Study | ||||||||
| Official Title ICMJE | A Retrospective Study to Assess the Outcome After Treatment With the Eight Plate System in Pediatric Patients | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-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:
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Growth modulation with Eight plate
Pediatric patients undergoing growth modulation with the Eight plate system |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 350 | ||||||||
| Estimated Completion Date | October 2013 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Months to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany, India, Switzerland, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01625975 | ||||||||
| Other Study ID Numbers ICMJE | 106309 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | AO Clinical Investigation and Documentation | ||||||||
| Study Sponsor ICMJE | AO Clinical Investigation and Documentation | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | AO Clinical Investigation and Documentation | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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