A safety and efficacy pilot study on the use of a continuous distraction spring in addition to growing rod surgery in children with congenital, neuromuscular or idiopathic spinal deformities.

A safety and efficacy pilot study on the use of a continuous distraction spring in addition to growing rod surgery in children with congenital, neuromuscular or idiopathic spinal deformities. - GRADS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56121

Enrollment

160

Registered

2016-06-29

Start date

2016-09-26

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliose scoliosis Spinal growth deformities

Interventions

Addition of a distraction spring to current growth guidance systems.

Eligibility

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: Deformity Indicated for surgical treatment Open triradiate cartilage Normal skeletal development Informed consent

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
(Serious) adverse events.	—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)