Non Fusion Surgery in Adolescent Idiopathic Scoliosis Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

The primary objective of the study is to monitor the effectiveness of a minimal invasive non-fusion double rod bipolar posterior spinal implant (Nemost growing domino) to correct the scoliotic curve in growing patients suffering from progressive adolescent idiopathic scoliosis (AIS) who have failed conservative treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adolescent idiopathic scoliosis ;

Primary Cobb angle greater than 30°;

Failed non-operative treatment defined as progression of the curve greater than 5° per year at any time;

Skeletally immature (Risser grade* ≤2 and Skeletal age of hand and wrist X-rays ≤14y);

Disqualifiers

Non-idiopathic scoliosis: musculoskeletal or neurologic conditions responsible for cause of the spine curvature (i.e. neuromuscular, congenital or syndromic scoliosis);

History of previous spine surgery;

Risser sign >2;

Disease or deformity likely to affect the stability of the device (i.e. inadequate anatomy of pedicles, trauma or tumor in fixation region, severe osteoporosis, bone destruction or poor bone quality);

Trial design

Design model

Single group

Treatments tested in this trial

  • NEMOST system

    Device

    Minimal invasive double rod posterior Non-Fusion Scoliosis Surgery

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: NEMOST-AISOther 1 intervention

Trial outcomes

Primary outcomes

1

Coronal balance (Correction of the primary curvature on radiograph

Cobb angle (degrees)

Time frame
2 years
2

T1-S1 length on radiograph

length (cm)

Time frame
2 years
3

instrument segment length on radiograph

length (cm)

Time frame
2 years
4

(Serious) Adverse Event

complications

Time frame
2 years

Secondary outcomes

1

Vertebral rotation

scoliometer assesment

Time frame
2 years
2

Patient Reported Outcome (PRO

Scoliosis Research Society's-22 questionnaire

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.