SECURE®-C Cervical Artificial Disc Clinical Study/ SECURE-C Cervical Artificial Disc Postmarket Approval Study

NCT00882661 | Completed Results

• 1 other identifier: GPR002
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECURE®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion. The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc

Conditions

Symptomatic Cervical Disc Disease

Keywords

Neck Pain; Arm Pain

Outcome Measures

Primary Outcomes (1)

• Individual Patient Overall Success

  Individual patient overall success defined as pain/disability improvement of at least 25% in Neck Disability Index (NDI) compared to baseline; no device failures requiring revision, removal, reoperation, or supplemental fixation; absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and for control fusion patients only, radiographic fusion

  24 months

Secondary Outcomes (7)

• Neck Disability Index (NDI)

  24 months

• Neck Pain Visual Analog Scale (VAS)

  24 months

• Left Arm Pain Visual Analog Scale (VAS)

  24 months

• Right Arm Pain Visual Analog Scale (VAS)

  24 months

• SF-36 PCS

  24 months

Study Arms (2)

SECURE-C Cervical Artificial Disc

EXPERIMENTAL

Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc

Device: SECURE-C Cervical Artificial Disc

ASSURE Cervical plate and an allograft interbody spacer

ACTIVE COMPARATOR

Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion

Device: ASSURE Cervical plate and an allograft interbody spacer

Interventions

SECURE-C Cervical Artificial Disc DEVICE

Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc

SECURE-C Cervical Artificial Disc

ASSURE Cervical plate and an allograft interbody spacer DEVICE

Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion

ASSURE Cervical plate and an allograft interbody spacer

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
• Herniated nucleus pulposus;
• Radiculopathy or myelopathy;
• Spondylosis (defined by the presence of osteophytes); or
• Loss of disc height.
• Age between 18 and 60 years
• Failed at least 6 weeks of conservative treatment
• Neck Disability Index (NDI) Questionnaire score of at least 30 (as percentage of 50 point total)
• Able to understand and sign informed consent form
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and filling out forms
• Able to meet the proposed follow-up schedule at 6 weeks, 3 months, 6 months, 12 months and 24 months
• Able to follow postoperative management program

You may not qualify if:

• More than one vertebral level requiring treatment
• Prior fusion surgery adjacent to the vertebral level being treated
• Prior surgery at the level to be treated
• Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
• Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve
• Marked cervical instability on resting lateral or flexion/extension radiographs:
• Translation greater than 3mm, and/or
• More than 11° of rotational difference from that of either adjacent level.
• Severe spondylosis at the level to be treated as characterized by any of the following:
• Bridging osteophytes;
• A loss of disc height greater than 50%; or
• Absence of motion (\<2°)
• Neck or arm pain of unknown etiology
• Osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease
• Pregnant or interested in becoming pregnant in the next 2 years

Sponsors & Collaborators

• Globus Medical Inc: lead

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jacqueline Myer
• Organization: Globus Medical

jmyer@globusmedical.com

610-930-1800

Study Officials

• Joseph M Marzluff, MD

  Trident Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 16, 2009
• Study Start: July 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: February 1, 2017
• Last Updated: June 9, 2017
• Results First Posted: June 9, 2017

Record last verified: 2017-06