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

Last updated: November 13, 2024
Sponsor: NGMedical GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Radiculopathy

Spinal Stenosis

Spondylolisthesis

Treatment

MOVE®-C

Clinical Study ID

NCT05035693
P004
DRKS00022971
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramenand spinal canal,

  2. documented individual history of neck and/or upper extremity pain and/orfunctional/neurological deficit associated with the cervical level to be treated,

  3. no surgical treatment regarding the planned index surgery within the last six weeksprior implantation,

  4. unsuccessful conservative medical care regarding the indication within the last sixweeks,

  5. age ≥18 years,

  6. patient must agree to fully participate in the clinical trial and give informedconsent in writing,

  7. patient is capable to realise the nature, aims and possible consequences of theclinical trial (MPG §20.2.1),

  8. patient information has been provided and all written consents of the patient areavailable.

Exclusion

Exclusion Criteria:

  • Known contraindication against the use of cervical intervertebral disc prostheses inaccordance 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. posteriorelement decompression),

  9. advanced cervical anatomical deformity at the operative site (e.g. ankylosingspondylitis, 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 Design

Total Participants: 170
Treatment Group(s): 1
Primary Treatment: MOVE®-C
Phase:
Study Start date:
March 11, 2021
Estimated Completion Date:
March 11, 2027

Study 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.

Connect with a study center

  • Wiener Gesundheitsverbund-Klinik Penzing

    Wien, 1180
    Austria

    Active - Recruiting

  • DRK Klinikum Berlin

    Berlin, 14050
    Germany

    Active - Recruiting

  • Wirbelsäulenzentrum Fulda Main, Kinzig

    Gelnhausen, 63571
    Germany

    Active - Recruiting

  • Medizinisches Versorgungszentrum Steinburg

    Itzehoe, 25524
    Germany

    Active - Recruiting

  • Stätisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133
    Germany

    Site Not Available

  • Katholisches Klinikum Koblenz - Montabaur

    Koblenz, 56073
    Germany

    Active - Recruiting

  • Neurochirurgie am Gasteig

    München, 81669
    Germany

    Active - Recruiting

  • Rhein-Maas Klinikum Würselen

    Würselen, 52146
    Germany

    Active - Recruiting

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