NCT04441411

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2020Dec 2028

Study Start

First participant enrolled

June 1, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

6.6 years

First QC Date

June 11, 2020

Last Update Submit

July 29, 2024

Conditions

Adolescent Idiopathic Scoliosis

Keywords

scoliosisnonfusionsurgeryfusionlessidiopathicadolescent

Outcome Measures

Primary Outcomes (6)

  • Coronal balance (Correction of the primary curvature on radiograph

    Cobb angle (degrees)

    2 years

  • T1-S1 length on radiograph

    length (cm)

    2 years

  • instrument segment length on radiograph

    length (cm)

    2 years

  • (Serious) Adverse Event

    complications

    2 years

  • Sagittal balance (thoracic kyphosis, lumbar lordosis, proximal and distal junctional angle)

    Cobb angle (degrees)

    2 years

  • Pelvic parameters (pelvic obliquity, sacral slope, pelvic incidence, pelvic tilt)

    degrees

    2 years

Secondary Outcomes (2)

  • Vertebral rotation

    2 years

  • Patient Reported Outcome (PRO

    2 years

Study Arms (1)

NEMOST-AIS

OTHER

This study is designed as a cohort study.

Device: NEMOST system

Interventions

NEMOST systemDEVICE

Minimal invasive double rod posterior Non-Fusion Scoliosis Surgery

NEMOST-AIS

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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);
  • In girl, either pre-menarchal or post-menarchal by no more than 1 year;
  • Age over 10 years;
  • Non rigid curve;
  • All Lenke type;
  • No previous spine surgery.

You may not qualify if:

  • 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);
  • Non-reductible scoliosis;
  • Known allergy or intolerance to one of the device material;
  • Acute or chronic infections, local or systemic;
  • Absence or insufficience of covering tissues;
  • Pathological obesity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AmsterdamUMC, location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Publications (1)

  • Post AM, Berends HI, van Royen BJ. Minimally Invasive Posterior Spinal Nonfusion Surgery in Patients With Adolescent Idiopathic Scoliosis Using a Bipolar One-Way Self-Expanding Rod System: Protocol for a Single-Center Clinical Cohort Study. JMIR Res Protoc. 2023 Dec 25;12:e47222. doi: 10.2196/47222.

    PMID: 38145474DERIVED

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • BJ Van Royen, MD, PhD

    AmsterdamUMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BJ Van Royen, MD, PhD

CONTACT

+31(0)5662672bj.vanroyen@amsterdamumc.nl

AMC AmsterdamUMC

CONTACT

+31(0)205669111amcfoundation@amc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor, principal investigator

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 22, 2020

Study Start

June 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)