Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)

August 31, 2013 updated by: SpinalMotion

Clinical Study Protocol for the Investigation of the Kineflex|C Spinal System - a Pivotal Study in Continued Access Stage

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The Kineflex|C disc is a 3-piece modular design consisting of two cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in two foot print sizes.

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Tower Orthopedics and Sports Medicine
      • Oakland, California, United States, 94612
        • Kaiser Foundation Research Institute
      • San Diego, California, United States, 92103
        • University of California San Diego
    • Colorado
      • Loveland, Colorado, United States, 80538
        • Rocky Mountain Associates in Orthopedic Medicine, P.C.
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory Orthopaedics & Spine Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Spine Institute of Louisiana
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Maryland Brain and Spine Center
      • Towson, Maryland, United States, 21204
        • Orthopaedic Associates, P.A
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Nevada
      • Reno, Nevada, United States, 89509
        • Sierra Regional Spine Institute
    • New York
      • Hamilton, New York, United States, 13346
        • Hamilton Orthopaedic Surgery and Sports Medicine
      • Mount Kisco, New York, United States, 10549
        • Northern Westchester Hospital
      • New York, New York, United States, 10021
        • Manhattan Orthopaedics, P.C.
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Carolina Neurosurgery and Spine Associates
      • Durham, North Carolina, United States, 27704
        • Triangle Orthopaedic Associates, P.A.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Univ. of Pittsburgh Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Semmes-Murphy Clinic
    • Texas
      • Plano, Texas, United States, 75093
        • Plano Orthopedic Sports Medicine & Spine Center
      • Plano, Texas, United States, 75093
        • SpineMark CRO at Texas Back Institue
      • Tyler, Texas, United States, 75701
        • Gordon Spine Associates
    • Washington
      • Kirkland, Washington, United States, 98034
        • Orthopedics International Spine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • any terminal, systemic or autoimmune disease;
  • metabolic bone disease (e.g., osteoporosis, gout, osteomalacia, Paget's disease);
  • any disease, condition or surgery which might impair healing;
  • known metal allergy;
  • arachnoiditis;
  • currently experiencing an episode of major mental illness;
  • pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery;
  • morbid obesity; use of spinal stimulator at any cervical level prior to surgery;
  • currently a prisoner;
  • currently involved in spinal litigation which may influence the subjects reporting of symptoms; OR
  • lives more than 300 miles from study center or participation in any other investigational drug, biologic, or medical device study within the last 30 days prior to study surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kineflex-C
Device: Artificial disk
Implant
Device: Artificial disc
Implant
Active Comparator: ACDF
Device: Artificial disk
Implant
Device: Artificial disc
Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline
Time Frame: 24 months
24 months
No major device related adverse events
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline
Time Frame: 24 months
24 months
Time to recovery
Time Frame: 24 months
24 months
Disc height at 24 months compared to baseline
Time Frame: 24 months
24 months
Adjacent level deterioration at 24 months compared to baseline
Time Frame: 24 months
24 months
Progressive facet disease at 24 months compared to baseline
Time Frame: 24months
24months
Displacement or migration of the device
Time Frame: 24 months
24 months
Odom's Criteria
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SpinalMotion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 7, 2006

First Submitted That Met QC Criteria

September 7, 2006

First Posted (Estimate)

September 11, 2006

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

August 31, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kineflex|C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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