Actively Recruiting
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
Led by NGMedical GmbH · Updated on 2024-11-15
170
Participants Needed
7
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of discopathy or herniated disc with radiculopathy or stenosis of the foramen and spinal canal
- History of neck and/or upper extremity pain or functional/neurological deficit related to the cervical level to be treated
- No cervical spine surgery within the last six weeks before implantation
- Unsuccessful conservative medical care within the last six weeks
- At least 18 years of age
- Patient agrees to fully participate and provides written informed consent
- Patient is capable of understanding the nature, aims, and possible consequences of the trial
- Patient information has been provided and all consent forms are completed
You will not qualify if you...
- Bone mineral density T-score .5 or lower for men aged 60 or older and women aged 50 or older as measured by spine DXA
- Active systemic infection or infection at the surgical site
- Sustained osteoporotic fracture of spine, hip, or wrist
- Presence of spinal metastases
- Known allergy to titanium or polycarbonate-urethane
- Confirmed pregnancy
- Severe cervical myelopathy
- Need for treatments that destabilize the spine (e.g., posterior element decompression)
- Advanced cervical anatomical deformity at surgery site (e.g., ankylosing spondylitis, scoliosis)
- Advanced degenerative changes at the vertebral level to be treated (e.g., spondylosis)
- Patient under judicial or official institutional orders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Wiener Gesundheitsverbund-Klinik Penzing
Vienna, Austria, 1180
Actively Recruiting
2
DRK Klinikum Berlin
Berlin, Germany, 14050
Actively Recruiting
3
Wirbelsäulenzentrum Fulda Main, Kinzig
Gelnhausen, Germany, 63571
Actively Recruiting
4
Medizinisches Versorgungszentrum Steinburg
Itzehoe, Germany, 25524
Actively Recruiting
5
Katholisches Klinikum Koblenz - Montabaur
Koblenz, Germany, 56073
Actively Recruiting
6
Neurochirurgie am Gasteig
München, Germany, 81669
Actively Recruiting
7
Rhein-Maas Klinikum Würselen
Würselen, Germany, 52146
Actively Recruiting
Research Team
S
Saskia Mathieu, M.Sc.
CONTACT
N
Nino Weiland, B.Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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