'Evaluation of respiratory muscle function after posterior scoliosis surgery, using dynamic MRI and exercise tests'

Withdrawn

• Conditions: Adolescent Idiopathic Scoliosis; back curvature; 10028302; 10013369; 10005944

• Registration Number: NL-OMON37850
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

• Patients diagnosed with AIS;
• Skeletally mature as can be derived from menarche, growth velocity, pubertal or skeletal status.
• Aged >=10 and <16 years of age.

Exclusion Criteria

• Spinal pathology other than idiopathic scoliosis
• Immature bones
• Previous spinal surgery
• Patients with primary acute or chronic pulmonary disease (e.g. asthma or cystic fibrosis)
• Patients who are likely to have muscle weakness, based on presence of neuromuscular disease or mental impairment.
• All contra-indications for MR Imaging
• Any type of physical incapacity or other pathologies that contraindicate cardio-pulmonary exercise test or pulmonary function test

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameter is the respiratory muscle strength, endurance, work of<br /><br>breathing and power 6 months and 2 weeks preoperatively and 6, 12 and 24 months<br /><br>postoperatively. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters include: The three-dimensional (3-D) orientation of the<br /><br>diaphragm and thorax, using dynamic MR Imaging; Pulmonary function during<br /><br>exercise, using exercise tests; Quality of life, using SRS-22r questionnaires;<br /><br>Changes in the intervertebral disc (configuration of the *high-<br /><br>intensity-zones*), using T1rho MRI.</p><br>