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

"PMCF MOVE®-C" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics

Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG.

Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.

Study Overview

• Status: Recruiting
• Conditions: Radiculopathy; Stenoses, Spinal; Discopathy; Herniated Cervical Disc
• Intervention / Treatment: Device: MOVE®-C

Detailed Description

This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge concerning the development of patients' quality of life (QoL) after the implantation of the Cervical Disc Prosthesis MOVE®-C and to collect data for the analysis of the range of motion (ROM), which is an essential parameter for motion-preserving implants.

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saskia Mathieu, M.Sc.; Phone Number: +49687399997118; Email: smathieu@ngmedical.de
• Study Contact Backup: Name: Nino Weiland, B.Sc.; Phone Number: +49687399997104; Email: nweiland@ngmedical.de

Study Locations

• Austria
  • Wien, Austria, 1180
    • Recruiting
    • Wiener Gesundheitsverbund-Klinik Penzing
    • Contact: Ronald Sabitzer, OA; Phone Number: 0043 6767017974; Email: ronald.sabitzer@gesundheitsverbund.de
• Germany
  • Berlin, Germany, 14050
    • Recruiting
    • DRK Klinikum Berlin
    • Contact: Olaf Süss, PD Dr.med.; Phone Number: +493030354260; Email: olaf.suess@drk-kliniken.de
    • Contact: Sven Mularski, Dr.med.; Phone Number: +493030354260; Email: sven.mularski@drk-kliniken.de
    • Sub-Investigator: Björn Kühn, Dr. med.
    • Sub-Investigator: Thomas Langer, Dr.med
  • Gelnhausen, Germany, 63571
    • Recruiting
    • Wirbelsäulenzentrum Fulda Main, Kinzig
    • Contact: Bernd Hölper, Dr. med.; Email: b.hölper@neuro-chirurgie.de
    • Contact: Yasmin Mitsikari; Email: y.mitsikari@neuro-chirurgie.de
  • Itzehoe, Germany, 25524
    • Recruiting
    • Medizinisches Versorgungszentrum Steinburg
    • Contact: Ardeshir Ardeshiri, Dr. med.; Phone Number: 0049- 821-7726702; Email: aardeshiri@aol.com
    • Contact: Lisa-Marie Feldhaus; Phone Number: 0049- 821-7726702; Email: L.Feldhaus@KH-Itzehoe.de
  • Koblenz, Germany, 56073
    • Recruiting
    • Katholisches Klinikum Koblenz - Montabaur
    • Contact: Francis K Kilian, Dr.med.; Phone Number: 0049 261 496-6457; Email: f.kilian@kk-km.de
    • Contact: Nina Schroeder; Phone Number: 0049 261 496-6457; Email: n.schroeder@kk-km.de
    • Sub-Investigator: Bernhard Bruchmann, Dr.med.
  • München, Germany, 81669
    • Recruiting
    • Neurochirurgie am Gasteig
    • Contact: Ardavan Ardeshiri, Dr. med.; Phone Number: 0049 896666339040; Email: ardeshiri@neurochirurgie-am-gasteig.de
    • Contact: Jenifer Kilian; Phone Number: 0049 896666339040; Email: jkilian@neurochirurgie-am-gasteig.de
  • Würselen, Germany, 52146
    • Recruiting
    • Rhein-Maas Klinikum Würselen
    • Contact: Rolf Sobottke, Prof.Dr.med.; Phone Number: 0049 2405623372; Email: rolf.sobottke@rheinmaasklinikum.de
    • Contact: Khaled Allan; Phone Number: 0049-2405-62-8258; Email: allan.khaled@rheinmaasklinikum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,
2. documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated,
3. no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,
4. unsuccessful conservative medical care regarding the indication within the last six weeks,
5. age ≥18 years,
6. patient must agree to fully participate in the clinical trial and give informed consent in writing,
7. patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1),
8. patient information has been provided and all written consents of the patient are available.

Exclusion Criteria:

• Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:

  1. Bone mineral density with T-score ≤ -1.5 as determined by spine DXA if male ≥ 60 years of age or female ≥ 50 years of age,
  2. active systemic infection or infection at the operative site,
  3. sustained osteoporotic fracture of the spine, hip or wrist,
  4. spinal metastases,
  5. known allergy to titanium or polycarbonate-urethane,
  6. confirmed pregnancy,
  7. severe cervical myelopathy,
  8. patients requiring a treatment that destabilises the spine (e.g. posterior element decompression),
  9. advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis),
  10. advanced degenerative changes (e.g. spondylosis) at the index vertebral level,
  11. patient is kept in an institution under judicial or official orders (MPG §20.3).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PMCF MOVE-C; PMCF MOVE®_C is a single arm observational study with 170 patients.	Device: MOVE®-C; Momo- or bisegmental implantation of MOVE®-C cervical prothesis.; Other Names: cervical disc prothesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Core Outcome Measure Index (COMI neck)	The clinical results of COMI neck will be compared to the 24 months visit before the operation.	Baseline and months 24
Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36)	The clinical results of SF-36 will be compared to the 24 months visit before the operation.	Baseline and moths 24
Change from baseline in EuroQoL (EQ-5D-5L)	The clinical results of (EQ-5D-5L) will be compared to the 24 months visit before the operation.	Baseline and moths 24
Change from baseline in Japanese Orthopedic Association Score (JOA)	The clinical results of (JOA) will be compared to the 24 months visit before the operation.	Baseline and moths 24
Analyse of the Range of Motion (ROM)	The radiological results of the ROM are compared to the 24 months visit before the operation.	Baseline and moths 24
Monitoring of product related occurence of adverse events (AE-Monitoring)	The radiological results of the AE-Monitoring are compared to the 24 months visit before the operation.	Baseline and moths 24

Collaborators and Investigators

• Sponsor: NGMedical GmbH
• Investigators: Principal Investigator: Olaf Süss, PD Dr. med., DRK Kliniken Berlin

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Anticipated): March 11, 2024
• Study Completion (Anticipated): March 11, 2026

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Herniated Disc; Radiculopathy; Cervical Spine; Discopathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Radiculopathy; Spinal Stenosis
• Other Study ID Numbers: P004; DRKS00022971 (Other Identifier: Deutsches Register Klinischer Studien)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be available for other researchers, that will not be a study site in this clinical trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No