Limited-efficacy Testing of SDS and NEMOST for Early Onset Neuromuscular Scoliosis

NCT04021784 | Completed DMC

• 1 other identifier: NL 64018.041.17
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

The primary aim of this study is to investigate and describe the limited efficacy of the Spring Distraction System (SDS) and Bilateral One Way Rod (NEMOST) in maintaining curve reduction without repeat lengthening procedures and complications. Secondary aims are to describe growth of the instrumented spine, health-related quality of life, and to compare both devices.

Conditions

Neuromuscular Scoliosis; Distraction System; Growth Friendly System

Outcome Measures

Primary Outcomes (2)

• Limited-efficacy of SDS and NEMOST in terms of curve correction maintenance

  Changes in cobb angle on radiographs post-op and at 4 weeks, 3 months, 6 months and 12 months follow-up (FU). A maximum of 5 degrees increase will be the threshold to define maintenance.

  Until 1 year post-operatively

• Incidence of possible Treatment-Emergent Serious Adverse Events of SDS and NEMOST

  Reported treatment related Serious Adverse Events (SAEs) per-operatively and at 4 weeks, 3 months, 6 months and 12 months FU.

  Until 1 year post-operatively

Secondary Outcomes (12)

• Limited-efficacy of SDS and NEMOST in terms of spinal length

  Until 1 year post-operatively

• SDS vs. NEMOST with respect to limited-efficacy in terms of curve correction maintenance

  Until 1 year post-operatively

• SDS vs. NEMOST with respect to limited-efficacy in terms of spinal length

  Until 1 year post-operatively

• SDS vs. NEMOST with respect to the development of the sagittale profile and instrumented thoracic kyphosis

  Until 1 year post-operatively

• SDS vs. NEMOST with respect to surgery time

  Until 1 year post-operatively

Study Arms (2)

Spring Distraction System (SDS)

EXPERIMENTAL

The SDS will be placed and fits around a standard rod of 5.5mm.

Device: SDS

Necker Enfants Malade OSTeosynthesis (NEMOST)

EXPERIMENTAL

The NEMOST is a one-way-rod that uses a ratchet type of locking mechanism. Both NEMOST devices should be placed in parallel, on the two fixator rods that are connected with a cross connector

Device: NEMOST

Interventions

SDS DEVICE

The patient is implanted with SDS.

Spring Distraction System (SDS)

NEMOST DEVICE

The patient is implanted with NEMOST.

Necker Enfants Malade OSTeosynthesis (NEMOST)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Non ambulant
• Neuromuscular or syndromal scoliosis
• Progressive scoliosis indicated for bipolar fixation extending to the pelvis
• Diagnosis of scoliosis before age 10
• Patient under 12 and open triradiate cartilage (usually closes around 12 years for girls and 14 years for boys)
• Main curve proximal end vertebra below Th 3
• Non rigid curve
• Patients who have an indication for a primary surgery

You may not qualify if:

• Ambulant
• Patients with closed triradiate cartilage
• Patients with a skeletal dysplasia that effects growth (Achondroplasia, SED)
• Patients with a systemic disease which severely influences bone quality e.g. osteogenesis imperfecta, metabolic diseases
• Patients with soft tissue weakness (Ehler Danlos, Marfan, Neurofibromatosis, Prader Willi)
• Patients that have a congenital anomaly of the spine of more than 5 vertebrae
• Patients with an active systemic disease such as JIA, HIV, oncologic treatment
• Patients with a previous surgical fusion of the spine
• Patients that are expected to be lost to FU due to e.g. likely to immigrate within 1 year.
• Patients that have had a previous spine surgery.

Sponsors & Collaborators

• UMC Utrecht: lead
• EUROS: collaborator

Study Sites (3)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

UMC Utrecht

Utrecht, 3584CX, Netherlands

Location

Related Publications (1)

• Lemans JVC, Tabeling CS, Scholten EP, Stempels HW, Miladi L, Castelein RM, Kruyt MC. Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR). BMC Musculoskelet Disord. 2023 Jan 10;24(1):20. doi: 10.1186/s12891-022-06048-4.

  PMID: 36627616 DERIVED

Related Links

• Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR)

Study Officials

• Moyo C Kruyt, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient is blinded to the medical device until after surgery. This is done to prevent selection bias through withdrawal. Patients are unblinded post-operatively, to enable accurate patient counseling with radiographs, on which the implant can be clearly seen.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Model Details: Half of the patients will be implanted with SDS system, the other half will be implanted with NEMOST.

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: July 16, 2019
• Study Start: May 6, 2019
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)