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

NGMedical

Status: Enrolling

Conditions: Stenoses, Spinal; Herniated Cervical Disc; Radiculopathy; Discopathy

Treatments: Device: MOVE®-C

Study type: Interventional

Funder types: Industry

Identifiers

NCT05035693

P004

DRKS00022971 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

PMCF MOVE-C

Experimental group

Description:

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

Treatment:

Device: MOVE®-C