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Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study. An 18-month recruitment period is planned with a 4-year postoperative follow-up period for each subject. Thus, it is anticipated that the study will require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively, prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years postoperatively from the date of surgery.
The activ C Disc Prosthesis pursues the goal of restoring the disc function, the geometry and motion of the cervical disc. Its concept is based on a ball and socket joint, anchored between adjacent vertebral bodies. The modular prosthesis comprises the following elements: an inferior CoCr plate component anchored in the endplate of the caudal vertebral body. The UHMWPE inlay is securely fixed in this inferior component. The second element is the superior CoCr component, which is anchored in the end plate of the cranial vertebral body. It forms a ball joint with the inlay of the inferior plate component.
The activ C product range enables reconstruction of various disc heights as well as adaptation to the end plate sizes. Secure primary anchorage of the prosthesis to the vertebral bodies is achieved by convexly shaped superior end pla tes and fixation means (spikes and grooves on the superior end plate, a small keel on the inferior end plate), whereas secondary stability is facilitated by an osseointegrative Plasmapore® coating.
The objective of the study is to collect outcome information on the Activ® C Disc Prosthesis.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcome measured by the Neck Disability Index (NDI) | The primary endpoint of the study will be changes in the clinical outcome measured by the Neck Disability Index (NDI) as published by Vernon et. al. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) on severity of neck pain and arm pain (experienced in the pain-dominant arm) | 4 years | |
| Visual Analogue Scale (VAS) on frequency of neck pain and arm pain (experienced in the pain-dominant arm) | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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adult patients
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| Name | Affiliation | Role |
|---|---|---|
| Petr Suchomel, MD PhD | Neurocentre, Regional Hospital Liberec, Liberec, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Liberec | Liberec | 46063 | Czechia | |||
| Faculty Hospital Motol Prague |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24554334 | Result | Suchomel P, Jurak L, Antinheimo J, Pohjola J, Stulik J, Meisel HJ, Cabraja M, Woiciechowsky C, Bruchmann B, Shackleford I, Arregui R, Sola S. Does sagittal position of the CTDR-related centre of rotation influence functional outcome? Prospective 2-year follow-up analysis. Eur Spine J. 2014 May;23(5):1124-34. doi: 10.1007/s00586-014-3223-0. Epub 2014 Feb 20. | |
| 27258476 |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D009999 | Ossification, Heterotopic |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
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| Adjacent segment degeneration | 4 years |
| Postoperative angular motion on flexion/extension radiographs in the replaced segment | 4 years |
| Complication rates (device related and non-device related) | 4 years |
| Overall success rate | 4 years |
| Prague |
| 150 06 |
| Czechia |
| University Hospital Motol | Prague | 16000 | Czechia |
| Helsinki University Central Hospital | Helsinki | FI-00029 HUS | Finland |
| Charité Berlin | Berlin | 10709 | Germany |
| Berufsgenossenschaftliche Kliniken Bergmannstrost | Halle | 06112 | Germany |
| Katholisches Klinikum Koblenz | Koblenz | 56073 | Germany |
| Universität Rostock, Abteilung Neurochirurgie | Rostock | 18057 | Germany |
| Neurosurgery at Instituti Fisioterapici Ospitalieri IFO | Rome | 00114 | Italy |
| Warrington District General Hospital | Warrington | WA4 4LU | United Kingdom |
| Meisel HJ, Jurak L, Antinheimo J, Arregui R, Bruchmann B, Cabraja M, Caroli F, Kroppenstedt S, Kryl J, Pohjola J, Shackleford I, Sola S, Stosberg P, Stulik J, Woiciechowsky C, Suchomel P. Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses: clinical and radiographic outcome. J Neurosurg Spine. 2016 Nov;25(5):556-565. doi: 10.3171/2016.3.SPINE15810. Epub 2016 Jun 3. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |