Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C
NCT ID: NCT05035693
Last Updated: 2024-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2021-03-11
2027-03-11
Brief Summary
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Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PMCF MOVE-C
PMCF MOVE®\_C is a single arm observational study with 170 patients.
MOVE®-C
Momo- or bisegmental implantation of MOVE®-C cervical prothesis.
Interventions
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MOVE®-C
Momo- or bisegmental implantation of MOVE®-C cervical prothesis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
Yes
Sponsors
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NGMedical GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Olaf Süss, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
DRK Kliniken Berlin
Locations
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Wiener Gesundheitsverbund-Klinik Penzing
Vienna, , Austria
DRK Klinikum Berlin
Berlin, , Germany
Wirbelsäulenzentrum Fulda Main, Kinzig
Gelnhausen, , Germany
Medizinisches Versorgungszentrum Steinburg
Itzehoe, , Germany
Katholisches Klinikum Koblenz - Montabaur
Koblenz, , Germany
Neurochirurgie am Gasteig
München, , Germany
Rhein-Maas Klinikum Würselen
Würselen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DRKS00022971
Identifier Type: OTHER
Identifier Source: secondary_id
P004
Identifier Type: -
Identifier Source: org_study_id
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