To assess if the new operating technique is effective and safe.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Scoliose
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(Serious) adverse events.
Secondary outcome
Length increase on standard spinal radiographs, difference in score on a
validated scoliosis questionnaire: "revised Scoliosis Research Society 22-item
questionnaire" and "Early Onset Scoliosis Questionnaire". Vertebral dimensions
of the vertebrae measured on a (Bone)MRI-scan.
Background summary
Current treatment is placing a growth guidance system that has to be lengthened
every 2 years in order for the spine to grow. By adding a distraction spring to
the current systems, a continuous force can be delivered on the spine,
mitigating the need for lengthening surgeries. The hypothesis is that this new
surgical technique is effective and safe for use.
Study objective
To assess if the new operating technique is effective and safe.
Study design
A safety and efficacy pilot study
Intervention
Addition of a distraction spring to current growth guidance systems.
Study burden and risks
The benifit of avoiding the 2-yearly lengthening operations outweighs the risks
of adding a spring to an existing growth guidance system. The force excerted
from the distraction spring onto the growth guidance system is smaller than
other forces on the growth guidance system during the operation. The risk is
smal and the benefit can potentially be big. The (Bone)MRI-scan does not carry
any radiation risk.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Deformity Indicated for surgical treatment
Open triradiate cartilage
Normal skeletal development
Informed consent
Exclusion criteria
Closed triradiate cartilage
Systemic disease which severely influences bone quality
Disease that influences soft tissue quality
Abnormal skeletal development and growth
Patients that are expected to be lost to follow-up
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55705.041.16 |