Clinical trial NCT05035693: Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
Official title: "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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Discopathy
Herniated Cervical Disc
Stenoses, Spinal
Radiculopathy
Keywords: Herniated Disc
Cervical Spine
Discopathy
Radiculopathy
Lead sponsor: NGMedical GmbH
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Improvement from baseline on Neck Disability Index (NDI)
timeFrame: Baseline and month 24
measure: Improvement from baseline on Visual Analogue Scales (VAS arm/neck)
timeFrame: Baseline and month 24
Secondary outcomes:
measure: Change from baseline in Core Outcome Measure Index (COMI neck)
timeFrame: Baseline and months 24
measure: Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36)
timeFrame: Baseline and moths 24
measure: Change from baseline in EuroQoL (EQ-5D-5L)
timeFrame: Baseline and moths 24
measure: Change from baseline in Japanese Orthopedic Association Score (JOA)
timeFrame: Baseline and moths 24
measure: Analyse of the Range of Motion (ROM)
timeFrame: Baseline and moths 24
measure: Monitoring of product related occurence of adverse events (AE-Monitoring)
timeFrame: Baseline and moths 24
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Wiener Gesundheitsverbund-Klinik Penzing
city: Berlin
country: Germany
facility: DRK Klinikum Berlin
city: Gelnhausen
country: Germany
facility: Wirbelsäulenzentrum Fulda Main, Kinzig
city: Itzehoe
country: Germany
facility: Medizinisches Versorgungszentrum Steinburg
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz - Montabaur
city: München
country: Germany
facility: Neurochirurgie am Gasteig
city: Würselen
country: Germany
facility: Rhein-Maas Klinikum Würselen
Study officials:
affiliation: DRK Kliniken Berlin
name: Olaf Süss, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: