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New treatment option for Discopathy
Official title Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
ClinicalTrials.gov ID: NCT05035693
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,
- unsuccessful conservative medical care regarding the indication within the last six weeks,
- age ≥18 years,
You likely can't join if
- Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:
- 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,
- active systemic infection or infection at the operative site,
- sustained osteoporotic fracture of the spine, hip or wrist,
- spinal metastases,
- known allergy to titanium or polycarbonate-urethane,
See the full eligibility criteria
- 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,
- no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,
- unsuccessful conservative medical care regarding the indication within the last six weeks,
- age ≥18 years,
- patient must agree to fully participate in the clinical trial and give informed consent in writing,
- patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1),
- patient information has been provided and all written consents of the patient are available.
- Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:
- 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,
- active systemic infection or infection at the operative site,
- sustained osteoporotic fracture of the spine, hip or wrist,
- spinal metastases,
- known allergy to titanium or polycarbonate-urethane,
- confirmed pregnancy,
- severe cervical myelopathy,
- patients requiring a treatment that destabilises the spine (e.g. posterior element decompression),
- advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis),
- advanced degenerative changes (e.g. spondylosis) at the index vertebral level,
- patient is kept in an institution under judicial or official orders (MPG §20.3).
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
- Berlin, Germany
- Gelnhausen, Germany
- Itzehoe, Germany
- Koblenz, Germany
- München, Germany
- Würselen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria; Berlin, Germany; Gelnhausen, Germany; Itzehoe, Germany; Koblenz, Germany; München, Germany and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.