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

Sponsor
SpinalMotion (Industry)
Overall Status
Terminated
CT.gov ID
NCT00374413
Collaborator
(none)
343
Enrollment
21
Locations
2
Arms
97
Duration (Months)
16.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Artificial disk
  • Device: Artificial disc
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
343 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical Study Protocol for the Investigation of the Kineflex|C Spinal System - a Pivotal Study in Continued Access Stage
Study Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline [24 months]

  2. No major device related adverse events [24 months]

Secondary Outcome Measures

  1. Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline [24 months]

  2. Time to recovery [24 months]

  3. Disc height at 24 months compared to baseline [24 months]

  4. Adjacent level deterioration at 24 months compared to baseline [24 months]

  5. Progressive facet disease at 24 months compared to baseline [24months]

  6. Displacement or migration of the device [24 months]

  7. Odom's Criteria [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • SpinalMotion

Investigators

  • Principal Investigator: Fred Geisler, MD, Medical Monitor

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
SpinalMotion
ClinicalTrials.gov Identifier:
NCT00374413
Other Study ID Numbers:
  • Kineflex|C
First Posted:
Sep 11, 2006
Last Update Posted:
Sep 13, 2013
Last Verified:
Aug 1, 2013
Keywords provided by SpinalMotion
DDD
artificial disc
Additional relevant MeSH terms:
Intervertebral Disc Degeneration

Study Results

No Results Posted as of Sep 13, 2013