imited-efficacy testing of Spring Distraction System (SDS) and unilateral one-way rod (MID-C) for early onset scoliosis (UniPOWR study)

Withdrawn

Conditions: Early Onset Idiopathic Scoliosis
spine curve
10023213
10009720

Registration Number: NL-OMON48743

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 28

Inclusion Criteria

1. Ambulant skeletally immature children, 6-12 yrs. of age, with open triradiate cartilages on X-ray
2. Scoliosis diagnosis prior to the age 10
3. Diagnosis of idiopathic or mild syndromic scoliosis (e.g. 22q11DS, Trisomy 21 or 9, Coffin-Siris)
4. Progressive scoliosis qualified for growth system surgery
5. One curve for treatment with an apex below Th5 and a proximal end vertebra below Th2
6. The primary curve must be between 35 and 75 degrees coronal Cobb angle
7. The primary curve must be non-rigid (i.e. the curve reduces on bending X-rays to <35 degrees or >30% of the curve)
8. Normal or hypokyphotic sagittal alignment (Th5 -Th12 < 50 degrees) on lateral X-rays

Exclusion Criteria

1. Patients with an obvious neuromuscular disease
2. Patients that are severely mentally retarded
3. Patients with a scoliosis that extends to the pelvis or the cervicothoracic region
4. Patients with a main curve of more than 8 vertebra Cobb to Cobb
5. Patients with a skeletal dysplasia that effects growth (e.g. achondroplasia, SED)
6. Patients with a systemic disease which severely influences bone quality (e.g. osteogenesis imperfecta, metabolic diseases)
7. Patients with soft tissue weakness (e.g. Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
8. Patients with an active systemic disease such as JIA, HIV or oncologic treatment
9. Patients with a previous surgical fusion of the spine
10. Known allergy to titanium
11. Patients weighing less than 11.4 kg or morbidly obese
12. Patients that are expected to be lost to FU due to e.g. immigration
13. Patient (or parents) that are expected to be non-compliant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the limited-efficacy and safety of SDS and MID-C EOS for treatment of<br /><br>progressive early onset scoliosis in ambulant patients. The limited- efficacy<br /><br>will be determined in terms of maintenance of correction and will be compared<br /><br>with a cohort of 17 patients previously treated by us with an MCGR system.<br /><br>Safety will be assessed in terms of treatment related SAEs and compared to the<br /><br>previous cohort and literature</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1 To assess limited-efficacy in terms of length gain, Th1-Th12, T1-S1. The<br /><br>instrumented segment length will be measured on calibrated AP X-rays. Length<br /><br>gain will be compared to our previous cohort of MGCR patients and literature,<br /><br>including normal growth.<br /><br><br /><br>2 To compare the two systems with respect to:<br /><br>a) limited-efficacy (maintenance of correction and lenght gain) and safety<br /><br>(SAEs)<br /><br>b) Surgical parameters: surgery time, blood loss, length of hospital stay,<br /><br>recovery time, treatment related complications / reoperations<br /><br>c) Bone density changes of the bypassed vertebrae, as assessed with DEXA post<br /><br>op and 12 +/-3 months<br /><br>d) Parent reported) QOL and performance with the EOSQ-24 questionnaire<br /><br>e) Flexibility and 3D rotation of the spine based on echography<br /><br>f) 3D development of the spine based on MRI<br /><br>g) Patient overall appearance (shoulder balance, sagittal balance)</p><br>