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.

Recruiting

• Conditions: Scoliose; scoliosis; Spinal growth deformities

• Registration Number: NL-OMON56121
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>(Serious) adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Length increase on standard spinal radiographs, difference in score on a<br /><br>validated scoliosis questionnaire: revised Scoliosis Research Society 22-item<br /><br>questionnaire and Early Onset Scoliosis Questionnaire. Vertebral dimensions<br /><br>of the vertebrae measured on a (Bone)MRI-scan.</p><br>