Clinical trial NCT02492724: Activ C European Multicenter Study
Official title: Activ C Disc Prosthesis European Multi-Center Clinical Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intervertebral Disc Replacement
Degenerative Disc Disease
Keywords: cervical spine
total disc replacement (cTDR)
degenerative disc disease
activ® C
clinical outcome
long-term results
NDI
VAS
heterotopic ossification (HO)
range of motion (ROM)
adjacent segment degeneration
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Symptomatic single-level cervical degenerative disc disease with neck and/or arm
* pain and/or neurological deficit, confirmed by MR scan
* Single-level surgery and single-level implantation of prosthesis between C3 and C7
* Age between 18 - 65 years at the time of surgery
* Pre-operative disc space height of the segment to be operated of at least 3mm
* Unsuccessful adequate conservative treatment
* Patient understands the conditions of the study and is willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
* Patient signed Informed Consent

Exclusion Criteria:

* Major facet joint degeneration at the segment to be operated on
* Severe spondylosis at the segment to be operated on (bridging osteophytes, absence of motion (\<2°))
* Pre-operative disc space height of the segment to be operated on of less than 3mm
* Major cervical segmental instability at the segment to be operated on (translation ≥3,5 mm and/or ≥11° of rotational difference to that of either adjacent level)
* Previous trauma to the segment to be operated on resulting in compression or bursting

Primary outcomes:
measure: Clinical Outcome measured by the Neck Disability Index (NDI)
timeFrame: 4 years
Secondary outcomes:
measure: Visual Analogue Scale (VAS) on severity of neck pain and arm pain (experienced in the pain-dominant arm)
timeFrame: 4 years
measure: Visual Analogue Scale (VAS) on frequency of neck pain and arm pain (experienced in the pain-dominant arm)
timeFrame: 4 years
measure: Adjacent segment degeneration
timeFrame: 4 years
measure: Postoperative angular motion on flexion/extension radiographs in the replaced segment
timeFrame: 4 years
measure: Complication rates (device related and non-device related)
timeFrame: 4 years
measure: Overall success rate
timeFrame: 4 years
Other outcomes:
Locations:
city: Liberec
country: Czech Republic
facility: Regional Hospital Liberec
city: Prague 5
country: Czech Republic
facility: Faculty Hospital Motol Prague
city: Prague 6
country: Czech Republic
facility: University Hospital Motol
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Berlin
country: Germany
facility: Charité Berlin
city: Halle / Saale
country: Germany
facility: Berufsgenossenschaftliche Kliniken Bergmannstrost
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz
city: Rostock
country: Germany
facility: Universität Rostock, Abteilung Neurochirurgie
city: Rome
country: Italy
facility: Neurosurgery at Instituti Fisioterapici Ospitalieri IFO
city: Warrington
country: United Kingdom
facility: Warrington District General Hospital
Study officials:
affiliation: Neurocentre, Regional Hospital Liberec, Liberec, Czech Republic
name: Petr Suchomel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.