Trials Sponsors Conditions Drugs Pricing

Conditions

Discopathy Herniated Cervical Disc Radiculopathy Stenoses, Spinal

Keywords

Herniated DiscCervical SpineDiscopathyRadiculopathy

Outcome Measures

Primary Outcomes (2)

Improvement from baseline on Neck Disability Index (NDI)
Primary outcome measure 1 and 2 are combined endpoints. Improvement of the NDI of more than 15 points for a change (pre-postoperative) of up to 30 points with a standard deviation of 25 points.
Baseline and month 24
Improvement from baseline on Visual Analogue Scales (VAS arm/neck)
Primary outcome measure 1 and 2 are combined endpoints. Improvement of arm and neck pain scale (VAS arm/neck) of more than 2 points at a change (pre-postoperative) of 2.7 points with a standard deviation of 2.5 points.
Baseline and month 24

Secondary Outcomes (6)

Change from baseline in Core Outcome Measure Index (COMI neck)

Study Arms (1)

PMCF MOVE-C

EXPERIMENTAL

PMCF MOVE®\_C is a single arm observational study with 170 patients.

Device: MOVE®-C

Interventions

MOVE®-CDevice

Momo- or bisegmental implantation of MOVE®-C cervical prothesis.

Also known as: cervical disc prothesis

PMCF MOVE-C

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,
documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated,

Sponsors & Collaborators

NGMedical GmbH
Industrylead

Study Sites (7)

Wiener Gesundheitsverbund-Klinik Penzing

Vienna, 1180, Austria

RECRUITING

Ronald Sabitzer, OACONTACT0043 6767017974 ronald.sabitzer@gesundheitsverbund.de

DRK Klinikum Berlin

Berlin, 14050, Germany

RECRUITING

Olaf Süss, PD Dr.med.CONTACT+493030354260

MeSH Terms

Conditions

Spinal StenosisRadiculopathyIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

Olaf Süss, PD Dr. med.
DRK Kliniken Berlin
PRINCIPAL INVESTIGATOR

Central Study Contacts

Saskia Mathieu, M.Sc.

CONTACT

+49687399997118 smathieu@ngmedical.de

Nino Weiland, B.Sc.

CONTACT

+49687399997104

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 12, 2021

First Posted

September 5, 2021

Study Start

March 11, 2021

Actual (reported)

Primary Completion

March 11, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

PMCF MOVE-C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (1)

PMCF MOVE-C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations