- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04337151
Blood Titanium Analysis of Patients With MAGEC Spine Rods in the COVID-19 Environment
Magnetic Expansion Control (MAGEC) growth rods are used in the surgical treatment of children with scoliosis; the primary constituent metal alloy in these is titanium.
Since June 2019, the manufacturer has released two Urgent Field Safety Notices (FSN) relating to known issues with the function of the rods that increase the risk of early failure and unplanned revisions. The UK MHRA has issued two similar Medical Device Alerts (MDA) with the most recent MDA issued on 1st April 2020, stating that (1) MAGEC rods must not be implanted in the UK until further notice and (2) all patients already implanted with this device should be followed up as soon as is possible.
At the time of writing, hospitals across the world are facing incredible challenges in dealing with the COVID-19 pandemic. Due to this, virtually all planned clinic visits for MAGEC rod patients and X-ray appointments have been postponed to help reduce the risk of the virus spreading.
Recent retrieval studies have shown that mechanical wear and corrosion of these rods is common, with a risk that the debris generated is released into surrounding tissue. This wear and corrosion is thought to be the primary cause of implant failures and the underlying implant factors leading to the issuing of FSNs and MDAs.
Whilst titanium is known to be highly biocompatible, the baseline and toxic levels of this alloy in biological fluids are poorly understood. Additionally, a better understanding of blood titanium levels in patients with MAGEC rods may enable this to become a biomarker of wear and corrosion of the rods. This may help surgeons identify earlier those patients who may develop implant related problems.
Furthermore, in the current COVID-19 environment, a blood test to measure titanium levels may be one of the most suitable ways in which to continue patient monitoring (and identify those at greatest risk of implant related issues), in the absence of regular clinic visits.
Previous work from the RNOH involved a similar study investigating patients with titanium hip implants.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Stanmore, United Kingdom, HA74LP
- Recruiting
- Royal National Orthopaedic Hospital
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Contact:
- Harry Hothi, PhD
- Phone Number: +44 (0) 20 8909 5847
- Email: harry.hothi@nhs.net
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients that have been treated with, and still have, a MAGEC rod.
Exclusion Criteria:
- Patients that do not have a MAGEC rod implant.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Titanium level
Time Frame: Within 6 months
|
Within 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RNOH MAGEC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on MAGEC Rod
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University Hospital, LilleRecruitingMacular Degeneration | Cone Dystrophy | Cone Rod Dystrophy | Retinal Dystrophy, Cone-RodFrance
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National Eye Institute (NEI)RecruitingCone-Rod Degeneration | Rod-Cone DegenerationUnited States, Australia
-
Pixium Vision SACompletedRetinitis Pigmentosa | Choroideremia | Cone Rod DystrophyAustria, France, Germany
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SparingVisionRecruiting
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Food and Drug Administration (FDA)National Eye Institute (NEI)RecruitingAge-Related Macular Degeneration | Retinal Degeneration | Retinitis Pigmentosa | Usher Syndromes | Cone Dystrophy | Rod Dystrophy | Cone Rod Dystrophy | Hydroxychloroquine Retinopathy | Late-Onset Retinal Degeneration | Rod Cone DystrophyUnited States
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Pixium Vision SACompletedRetinitis Pigmentosa | Choroideremia | Cone Rod DystrophyAustria, Spain, United Kingdom, France, Germany
-
PYC TherapeuticsRecruitingRetinitis Pigmentosa | Eye Diseases, Hereditary | Retinal Dystrophies | Retinal Dystrophy Rod | Retinal Dystrophy Rod ProgressiveUnited States, Australia
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Intelligent Medical Implants GmbHUnknownRetinitis Pigmentosa | Choroideremia | Cone-Rod Dystrophy
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National Eye Institute (NEI)TerminatedInherited Retinal Degeneration | Inherited Ophthalmic DiseasesUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingHematopoietic Stem Cell Transplantation | Cord Blood Stem Cell Transplantation | Cord Blood TransplantationUnited States
Clinical Trials on MAGEC Spine Rod
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AO Innovation Translation CenterActive, not recruitingEarly Onset ScoliosisUnited Kingdom, Switzerland
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Medicrea, USA Corp.WithdrawnDegenerative Disc Disease | Spinal Stenosis | Spinal Fusion | Kyphoscoliosis | Scoliosis; Adolescence | Pseudoarthrosis of Spine | Kyphoses, Scheuermann
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Queen's UniversityDePuy OrthopaedicsWithdrawn
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Globus Medical IncUniversity of Michigan; Polaris Spine and Neurosurgery CenterWithdrawnKyphosisUnited States, Denmark
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Hospices Civils de LyonCompleted
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University Hospital Inselspital, BerneTerminated
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Shriners Hospitals for ChildrenCompletedScoliosisUnited States
-
Pediatric Spine FoundationColumbia UniversityRecruitingEarly-Onset Scoliosis Deformity of SpineUnited States, Canada, Finland, Hong Kong
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SpineSave AGNot yet recruitingSpondylarthritis | Instability Lumbar Spine | Degenerative Spondylolisthesis | Degenerative Lumbar Spinal Stenosis | Discopathy | Facet Joint Arthrosis
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Retina Foundation of the SouthwestCompletedRetinitis Pigmentosa | AMDUnited States