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

Primary Purpose

Degenerative Disc Disease (DDD)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artificial disk
Artificial disc
Sponsored by
SpinalMotion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease (DDD) focused on measuring DDD, artificial disc

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tower Orthopedics and Sports Medicine
  • Kaiser Foundation Research Institute
  • University of California San Diego
  • Rocky Mountain Associates in Orthopedic Medicine, P.C.
  • Emory Orthopaedics & Spine Center
  • Spine Institute of Louisiana
  • Maryland Brain and Spine Center
  • Orthopaedic Associates, P.A
  • William Beaumont Hospital
  • Sierra Regional Spine Institute
  • Hamilton Orthopaedic Surgery and Sports Medicine
  • Northern Westchester Hospital
  • Manhattan Orthopaedics, P.C.
  • Carolina Neurosurgery and Spine Associates
  • Triangle Orthopaedic Associates, P.A.
  • Univ. of Pittsburgh Medical Center
  • Semmes-Murphy Clinic
  • Plano Orthopedic Sports Medicine & Spine Center
  • SpineMark CRO at Texas Back Institue
  • Gordon Spine Associates
  • Orthopedics International Spine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kineflex-C

ACDF

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2006
Last Updated
August 31, 2013
Sponsor
SpinalMotion
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1. Study Identification

Unique Protocol Identification Number
NCT00374413
Brief Title
Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)
Official Title
Clinical Study Protocol for the Investigation of the Kineflex|C Spinal System - a Pivotal Study in Continued Access Stage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Economic and business factors
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SpinalMotion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease (DDD)
Keywords
DDD, artificial disc

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kineflex-C
Arm Type
Experimental
Arm Title
ACDF
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Artificial disk
Intervention Description
Implant
Intervention Type
Device
Intervention Name(s)
Artificial disc
Intervention Description
Implant
Primary Outcome Measure Information:
Title
Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline
Time Frame
24 months
Title
No major device related adverse events
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline
Time Frame
24 months
Title
Time to recovery
Time Frame
24 months
Title
Disc height at 24 months compared to baseline
Time Frame
24 months
Title
Adjacent level deterioration at 24 months compared to baseline
Time Frame
24 months
Title
Progressive facet disease at 24 months compared to baseline
Time Frame
24months
Title
Displacement or migration of the device
Time Frame
24 months
Title
Odom's Criteria
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Geisler, MD
Organizational Affiliation
Medical Monitor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tower Orthopedics and Sports Medicine
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Kaiser Foundation Research Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Rocky Mountain Associates in Orthopedic Medicine, P.C.
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Emory Orthopaedics & Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Spine Institute of Louisiana
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Maryland Brain and Spine Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Orthopaedic Associates, P.A
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Sierra Regional Spine Institute
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Hamilton Orthopaedic Surgery and Sports Medicine
City
Hamilton
State/Province
New York
ZIP/Postal Code
13346
Country
United States
Facility Name
Northern Westchester Hospital
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Manhattan Orthopaedics, P.C.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolina Neurosurgery and Spine Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Triangle Orthopaedic Associates, P.A.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Univ. of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Semmes-Murphy Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Plano Orthopedic Sports Medicine & Spine Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
SpineMark CRO at Texas Back Institue
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Gordon Spine Associates
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Orthopedics International Spine
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29303467
Citation
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.
Results Reference
derived
PubMed Identifier
21699471
Citation
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. Erratum In: J Neurosurg Spine. 2012 Mar;16(3):322.
Results Reference
derived
Links:
URL
http://www.spinalmotion.com
Description
Related Info

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

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