NCT00637312

Brief Summary

The purpose of this study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at least 18 years of age).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 27, 2014

Completed
Last Updated

March 27, 2014

Status Verified

February 1, 2014

Enrollment Period

3.3 years

First QC Date

March 10, 2008

Results QC Date

February 12, 2014

Last Update Submit

February 12, 2014

Conditions

Cervical Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Device and/or Procedure Related Adverse Event(s)

    At 24-months

Study Arms (2)

Advent™ Cervical Disc

EXPERIMENTAL

Cervical artificial disc replacement: Advent™ Cervical Disc

Device: Cervical Artificial Disc (Advent™ Cervical Disc)

Standard care - Control

ACTIVE COMPARATOR

Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System

Device: Hallmark™ Anterior Cervical Plate System

Interventions

Cervical Artificial Disc (Advent™ Cervical Disc)DEVICE

Advent™ Cervical Disc

Also known as: Advent™ Cervical Disc
Advent™ Cervical Disc
Hallmark™ Anterior Cervical Plate SystemDEVICE

Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)

Standard care - Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One cervical spine level between C3 and C7 which requires surgical treatment for intractable cervical radiculopathy and/or myelopathy demonstrated by herniated disc, and/or osteophyte formation leading to nerve root and/or spinal cord compression confirmed by patient history (e.g. neck and/or arm pain), functional and/or neurological deficit (e.g. numbness, weakness, diminished or pathologic reflexes, gait disturbances, etc.) and radiographic studies (e.g. CT, MRI, x-rays, etc.).
  • Unresponsive to conservative care over a period of at least 6 weeks
  • Neck Disability Index score ≥ 15/50 (30%)
  • Willing and able to comply with the requirements of the protocol including follow-up requirements and to sign a study specific informed consent

You may not qualify if:

  • More than 1 level requiring surgical treatment for intractable cervical radiculopathy and/or myelopathy.
  • Active local (at the proposed surgical site) or systemic infection
  • Prior anterior neck surgery at any level.
  • Prior posterior cervical spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved.
  • Currently undergoing treatment for disease of the thoracic or lumbar spine.
  • Axial neck pain as the primary diagnosis, without evidence of neural compression
  • Significant cervical anatomical deformity
  • Any anatomical consideration which in the investigators opinion would make the anterior cervical approach excessively risky or impossible
  • Severe obesity defined as a Body Mass Index (BMI) \> 40
  • Instability on AP, lateral neutral or flex/ext images: ≥2mm translation relative to the adjacent segment, and/or ≥ 11 degrees relative to adjacent segments
  • Central disc height ≤ 2mm
  • Advanced spondylosis (i.e. facet joints degeneration, anterior or posterior bridging of the interspace or lack of motion on the pre-operative flexion/extension x-rays)
  • Severe cervical myelopathy as indicated by: Signs and/or symptoms \> 6months duration, Nurick's Classification grades IV or V, and/or Myelomalacia as evidence on a MRI
  • Metabolic bone disease such as osteoporosis to a degree that spinal instrumentation is contra-indicated (Males over 55 years of age, females over 50 years of age and/or subjects that in the investigators opinion are medical indicative of osteoporosis (e.g. early menopause, steroid use, etc.) are required to have a DEXA scan; If the DEXA scan is ≤ -2.5t in the spine, the patient must be excluded)
  • Allergy to any component of the device (titanium, polycarbonated polyurethane, polyethylene terephthalate, or ethylene oxide residuals)
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of California Davis

Sacramento, California, 95816, United States

Location

Boulder Neurosurgical Associates

Boulder, Colorado, 80304, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Brain and Spine Specialist

Baltimore, Maryland, 21215, United States

Location

Cooper University Neurological Institute

Camden, New Jersey, 08103, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Triangle Orthopaedics Associates, P.A.

Durham, North Carolina, 27704, United States

Location

University of Pennsylvania, Department of Neurosurgery

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

East Tennessee Brain and Spine Center

Johnson City, Tennessee, 37604, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

The San Antonio Orthopaedic Group

San Antonio, Texas, 78216, United States

Location

Limitations and Caveats

The study was suspended for a high rate of adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent group. Approval is not being pursued and thus no analysis has been completed.

Results Point of Contact

Title
Ruba Sarris
Organization
Orthofix
rubasarris@orthofix.com
214-937-2256

Study Officials

  • Scott L Blumenthal, M.D.

    Texas Back Institute

    STUDY DIRECTOR

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

March 10, 2008

First Posted

March 17, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2011

Study Completion

February 1, 2013

Last Updated

March 27, 2014

Results First Posted

March 27, 2014

Record last verified: 2014-02

Locations

US(13)