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"PMCF MOVE4-C" International, Prospective, Multicentre, Non-randomised Post-market Clinical Follow-up Study Clinical and Radiological Outcome After Mono- and Bisegmental Cervical Intervertebral Disc Prosthetics
Led by NGMedical GmbH · Updated on 2024-11-15
170
Participants Needed
7
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an international, prospective, multicenter, non-randomized observational study to confirm the safety and performance of the cervical disc prosthesis MOVE4-C. The study also aims to understand how patients' quality of life changes after implantation and to assess the range of motion, which is important for implants that preserve movement. This research focuses on individuals with discopathy, herniated cervical discs, spinal stenoses, or radiculopathy. The study involves a single group of 170 patients who will receive a mono- or bisegmental implantation of the MOVE4-C cervical prosthesis. This device-based intervention is observed without randomization or a comparison group. The research collects clinical and radiological data to evaluate the device’s performance over time. There are no placebo or blinded treatments involved. Participants will be followed up from baseline through 24 months after implantation. Researchers will assess improvements in neck disability, arm and neck pain using the Neck Disability Index and Visual Analogue Scales, as well as other health and function measures like the Core Outcome Measure Index, SF-36, EuroQoL, and Japanese Orthopedic Association Score. Range of motion and any adverse events related to the device will be monitored. The study includes clinical visits and evaluations to collect these outcomes and ensure safety throughout the follow-up period.
CONDITIONS
Brief 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 disc hernia with radiculopathy or stenosis of the foramen and spinal canal
- Documented history of neck and/or upper extremity pain or functional/neurological deficit related to the cervical level to be treated
- No surgical treatment on the planned surgery site within the last six weeks before implantation
- Unsuccessful conservative medical care for the indication within the last six weeks
- Age 18 years or older
- Patient agrees to fully participate and gives written informed consent
- Patient understands the nature, aims, and possible consequences of the clinical trial
- Patient has received all necessary information and provided all written consents
You will not qualify if you...
- Bone mineral density T-score 2 -1.5 for males aged 60 or older and females aged 50 or older as measured by spine DXA
- Active systemic infection or infection at the surgical site
- Previous 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 treatment that destabilizes the spine, such as posterior element decompression
- Advanced cervical anatomical deformity at the surgical site, including ankylosing spondylitis or scoliosis
- Advanced degenerative changes at the index vertebral level, such as spondylosis
- Patient is under judicial or official orders in an institution according to MPG 20.3
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo mono- or bisegmental implantation of the MOVE®-C cervical disc prosthesis followed by immediate post-operative care.
1 surgical visit and 1 immediate post-operative visit
Duration - 24 months
Participants are monitored to assess safety, performance, and recovery after the implantation, including evaluations of quality of life and range of motion.
Visits at baseline and month 24, with additional assessments as needed
Trial Site Locations
Total: 7 locations
1
Wiener Gesundheitsverbund-Klinik Penzing
Vienna, Austria, 1180
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2
DRK Klinikum Berlin
Berlin, Germany, 14050
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3
Wirbelsäulenzentrum Fulda Main, Kinzig
Gelnhausen, Germany, 63571
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4
Medizinisches Versorgungszentrum Steinburg
Itzehoe, Germany, 25524
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5
Katholisches Klinikum Koblenz - Montabaur
Koblenz, Germany, 56073
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6
Neurochirurgie am Gasteig
München, Germany, 81669
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7
Rhein-Maas Klinikum Würselen
Würselen, Germany, 52146
Actively Recruiting
Research Team
S
Saskia Mathieu, M.Sc.
N
Nino Weiland, B.Sc.
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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