Retrospective Eight Plate Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Leg Length Discrepancy Varus/Valgus Deformities of the Knee |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | A Retrospective Study to Assess the Outcome After Treatment With the Eight Plate System in Pediatric Patients |
| Estimated Enrollment: | 350 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Growth modulation with Eight plate
Pediatric patients undergoing growth modulation with the Eight plate system
|
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.
Eligibility| Ages Eligible for Study: | 18 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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
Contacts and Locations| Contact: Denise Schmid | 0041442002477 | denise.schmid@aofoundation.org |
| Contact: Andreas Faeh |
| Germany | |
| Kinderchirurgische Klinik Städtisches Klinikum Karlsruhe | Recruiting |
| Karlsruhe, Germany, 76133 | |
| Contact: Michael von Knobloc, MD | |
| Principal Investigator: Michael von Knobloch, MD | |
| Klinikum Stuttgart | Recruiting |
| Stuttgart, Germany, 70176 | |
| Contact: ThomasM Wirth, Prof | |
| Principal Investigator: Thomas Wirth, Prof. Dr. | |
| India | |
| Sancheti Institute for Orthopaedics and Rehabilitation | Recruiting |
| Pune, India | |
| Contact: Sandeep Patwardhane, MD | |
| Principal Investigator: Sandeep Patwardhane, MD | |
| Switzerland | |
| Inselspital Bern | Recruiting |
| Bern, Switzerland | |
| Contact: Theddy Slongo, MD | |
| Hôpital des enfants | Recruiting |
| Genève, Switzerland, 1205 | |
| Contact: Dimitri Ceroni, M.D | |
| Principal Investigator: Dimitri CeroniM, MD | |
| Universitätskinderspital Zürich | Recruiting |
| Zürich, Switzerland, 8032 | |
| Contact: Leonhard Ramseier, MD | |
| Principal Investigator: Leonhard Ramseier, MD | |
| United Kingdom | |
| Guy Hilton Research Centre ISTM, Keele University | Not yet recruiting |
| Stoke-on-Trent, United Kingdom, ST4 7QB | |
| Contact: Jonathan Dwyer, MD | |
| Principal Investigator: Jonathan, Dwyer | |
| Principal Investigator: | Theddy Slongo, MD | University Hospital Inselspital, Berne |
More Information
No publications provided
| Responsible Party: | AO Clinical Investigation and Documentation |
| ClinicalTrials.gov Identifier: | NCT01625975 History of Changes |
| Other Study ID Numbers: | 106309 |
| Study First Received: | June 20, 2012 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by AO Clinical Investigation and Documentation:
|
Growth modulation Eight plate Leg length discrepancy Varus/valgus deformities Pediatric |
Additional relevant MeSH terms:
|
Congenital Abnormalities Leg Length Inequality Bone Diseases, Developmental |
Bone Diseases Musculoskeletal Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 23, 2013