NCT00374413

Brief Summary

The purpose of this study is to show that the Kineflex\|C Spinal System is no worse than conventional Anterior Cervical Diskectomy with Fusion (ACDF) in patients with single level degenerative disc disease at any cervical level from C3 to C7.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
343

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

21 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

July 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 13, 2013

Status Verified

August 1, 2013

Enrollment Period

4.5 years

First QC Date

September 7, 2006

Last Update Submit

August 31, 2013

Conditions

Degenerative Disc Disease (DDD)

Keywords

DDDartificial disc

Outcome Measures

Primary Outcomes (2)

  • Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline

    24 months

  • No major device related adverse events

    24 months

Secondary Outcomes (7)

  • Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline

    24 months

  • Time to recovery

    24 months

  • Disc height at 24 months compared to baseline

    24 months

  • Adjacent level deterioration at 24 months compared to baseline

    24 months

  • Progressive facet disease at 24 months compared to baseline

    24months

  • +2 more secondary outcomes

Study Arms (2)

Kineflex-C

EXPERIMENTAL
Device: Artificial diskDevice: Artificial disc

ACDF

ACTIVE COMPARATOR
Device: Artificial diskDevice: Artificial disc

Interventions

Artificial diskDEVICE

Implant

ACDFKineflex-C
Artificial discDEVICE

Implant

ACDFKineflex-C

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • have symptoms of cervical degenerative disc disease (DDD) at only one cervical level from C3 to C7, disc herniation on CT or MRI;
  • have radiculopathy symptoms in neck, one or both shoulders, and/or one or both arms;
  • have at least six months of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications and muscle relaxants at the manufacturer's recommended therapeutic dose), the presence of progressive symptoms (e.g., increasing numbness or tingling), or signs of nerve root compression;
  • have moderate disability neck disability index (NDI) score; AND
  • be likely to return for all follow-up visits and be willing and able to provide informed consent for study participation

You may not qualify if:

  • marked cervical instability;
  • non discogenic neck pain or non discogenic source of symptoms;
  • radiographic confirmation of severe facet disease or facet degeneration;
  • bridging osteophytes;
  • prior surgery at the level to be treated;
  • prior fusion at any cervical level;
  • more than one neck surgery via anterior approach;
  • previous trauma to the C3-C7 levels resulting in compression or bursting;
  • documented presence of free nuclear fragment at any cervical level;
  • severe myelopathy;
  • any paralysis;
  • history of chemical or alcohol dependence;
  • active systemic infection;
  • infection at the site of surgery;
  • prior disc space infection or osteomyelitis in the cervical spine;
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Tower Orthopedics and Sports Medicine

Beverly Hills, California, 90211, United States

Location

Kaiser Foundation Research Institute

Oakland, California, 94612, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Rocky Mountain Associates in Orthopedic Medicine, P.C.

Loveland, Colorado, 80538, United States

Location

Emory Orthopaedics & Spine Center

Atlanta, Georgia, 30329, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Maryland Brain and Spine Center

Annapolis, Maryland, 21401, United States

Location

Orthopaedic Associates, P.A

Towson, Maryland, 21204, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Sierra Regional Spine Institute

Reno, Nevada, 89509, United States

Location

Hamilton Orthopaedic Surgery and Sports Medicine

Hamilton, New York, 13346, United States

Location

Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

Location

Manhattan Orthopaedics, P.C.

New York, New York, 10021, United States

Location

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28207, United States

Location

Triangle Orthopaedic Associates, P.A.

Durham, North Carolina, 27704, United States

Location

Univ. of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Semmes-Murphy Clinic

Memphis, Tennessee, 38104, United States

Location

Plano Orthopedic Sports Medicine & Spine Center

Plano, Texas, 75093, United States

Location

SpineMark CRO at Texas Back Institue

Plano, Texas, 75093, United States

Location

Gordon Spine Associates

Tyler, Texas, 75701, United States

Location

Orthopedics International Spine

Kirkland, Washington, 98034, United States

Location

Related Publications (2)

  • Coric D, Guyer RD, Nunley PD, Musante D, Carmody C, Gordon C, Lauryssen C, Boltes MO, Ohnmeiss DD. Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc. J Neurosurg Spine. 2018 Mar;28(3):252-261. doi: 10.3171/2017.5.SPINE16824. Epub 2018 Jan 5.

    PMID: 29303467DERIVED

  • Coric D, Nunley PD, Guyer RD, Musante D, Carmody CN, Gordon CR, Lauryssen C, Ohnmeiss DD, Boltes MO. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine. 2011 Oct;15(4):348-58. doi: 10.3171/2011.5.SPINE10769. Epub 2011 Jun 24.

    PMID: 21699471DERIVED

Related Links

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Total Disc Replacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Fred Geisler, MD

    Medical Monitor

    PRINCIPAL INVESTIGATOR

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

September 7, 2006

First Posted

September 11, 2006

Study Start

July 1, 2005

Primary Completion

January 1, 2010

Study Completion

August 1, 2013

Last Updated

September 13, 2013

Record last verified: 2013-08

Locations

US(21)