Limited-efficacy Testing of Spring Distraction System (SDS) and Unilateral One-way Rod (MID-C) for Early Onset Scoliosis (UniPOWR)

UMC Utrecht

Status

Withdrawn

Conditions

Idiopathic Scoliosis

Early-Onset Scoliosis Deformity of Spine (Disorder)

Treatments

Device: SDS

Device: MID-C

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04003233

NL63511.041.17

Details and patient eligibility

About

The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of Early Onset Scoliosis (EOS) in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.

Full description

Rationale: EOS is a severe and potentially life-threatening disorder since a disturbance of spinal development leads to impaired development of the trunk, with cardio-respiratory failure as a result, often early in adult life. Several innovative solutions have been developed to treat growing children with severe EOS. The SDS device was developed internally at the dpt. of orthopedics at the UMC Utrecht, the Netherlands, the MID-C device was developed by the company ApiFix Ltd.

Objective: The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of early onset scoliosis in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.

Study design: A feasibility study using two prospective cohorts according to an open label randomized clinical trial (RCT) design. The study will be done in two tertiary referral centers (UMC Utrecht and Amsterdam UMC). Primary endpoints are maintenance of curve correction as well as complications. These data will be compared to a recently described cohort of patients that received a "standard treatment" (Magnetically controlled growing rod (MCGR)). The same endpoints as well as secondary outcomes, will be compared between the two new treatments.

Study population: Children with idiopathic(-like) early onset scoliosis with an indication for a growing rod implant.

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Patients with an obvious neuromuscular disease
Patients that are severely mentally retarded
Patients with a scoliosis that extends to the pelvis or the cervicothoracic region
Patients with a main curve of more than 8 vertebra Cobb to Cobb
Patients with a skeletal dysplasia that effects growth (e.g. achondroplasia, SED)
Patients with a systemic disease which severely influences bone quality (e.g. osteogenesis imperfecta, metabolic diseases)
Patients with soft tissue weakness (e.g. Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
Patients with an active systemic disease such as Juvenile Idiopathic Arthritis, HIV or oncologic treatment
Patients with a previous surgical fusion of the spine