Activ C European Multicenter Study

Degenerative Disc Disease Clinical Trial

Official title:

Activ C Disc Prosthesis European Multi-Center Clinical Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492724
• Other study ID #: AAG-O-H-0707
• Status: Completed
• Phase: N/A
• First received: July 6, 2015
• Last updated: July 8, 2015
• Start date: February 2007
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionCzech Republic: Ethics CommitteeFinland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2013
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Intervertebral Disc Replacement

Locations

Country	Name	City	State
Czech Republic	Regional Hospital Liberec	Liberec
Czech Republic	Faculty Hospital Motol Prague	Prague 5
Czech Republic	University Hospital Motol	Prague 6
Finland	Helsinki University Central Hospital	Helsinki
Germany	Charité Berlin	Berlin
Germany	Berufsgenossenschaftliche Kliniken Bergmannstrost	Halle / Saale
Germany	Katholisches Klinikum Koblenz	Koblenz
Germany	Universität Rostock, Abteilung Neurochirurgie	Rostock
Italy	Neurosurgery at Instituti Fisioterapici Ospitalieri IFO	Rome
United Kingdom	Warrington District General Hospital	Warrington

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Countries where clinical trial is conducted

Czech Republic,  Finland,  Germany,  Italy,  United Kingdom, 

References & Publications (1)

Suchomel P, Jurák 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 fo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Visual Analogue Scale (VAS) on severity of neck pain and arm pain (experienced in the pain-dominant arm)		4 years	No
Secondary	Visual Analogue Scale (VAS) on frequency of neck pain and arm pain (experienced in the pain-dominant arm)		4 years	No
Secondary	Adjacent segment degeneration		4 years	No
Secondary	Postoperative angular motion on flexion/extension radiographs in the replaced segment		4 years	No
Secondary	Complication rates (device related and non-device related)		4 years	No
Secondary	Overall success rate		4 years	No