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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00374413
Other study ID # Kineflex|C
Secondary ID
Status Terminated
Phase N/A
First received September 7, 2006
Last updated August 31, 2013
Start date July 2005
Est. completion date August 2013

Study information

Verified date August 2013
Source SpinalMotion
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 343
Est. completion date August 2013
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Intervention

Device:
Artificial disk
Implant
Artificial disc
Implant

Locations

Country Name City State
United States Maryland Brain and Spine Center Annapolis Maryland
United States Emory Orthopaedics & Spine Center Atlanta Georgia
United States Tower Orthopedics and Sports Medicine Beverly Hills California
United States Carolina Neurosurgery and Spine Associates Charlotte North Carolina
United States Triangle Orthopaedic Associates, P.A. Durham North Carolina
United States Hamilton Orthopaedic Surgery and Sports Medicine Hamilton New York
United States Orthopedics International Spine Kirkland Washington
United States Rocky Mountain Associates in Orthopedic Medicine, P.C. Loveland Colorado
United States Semmes-Murphy Clinic Memphis Tennessee
United States Northern Westchester Hospital Mount Kisco New York
United States Manhattan Orthopaedics, P.C. New York New York
United States Kaiser Foundation Research Institute Oakland California
United States Univ. of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Plano Orthopedic Sports Medicine & Spine Center Plano Texas
United States SpineMark CRO at Texas Back Institue Plano Texas
United States Sierra Regional Spine Institute Reno Nevada
United States William Beaumont Hospital Royal Oak Michigan
United States University of California San Diego San Diego California
United States Spine Institute of Louisiana Shreveport Louisiana
United States Orthopaedic Associates, P.A Towson Maryland
United States Gordon Spine Associates Tyler Texas

Sponsors (1)

Lead Sponsor Collaborator
SpinalMotion

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in Neck Disability Index (NDI) Score at 24 months compared with baseline 24 months No
Primary No major device related adverse events 24 months Yes
Secondary Clinically significant improvement in one or more radicular symptoms at 24 months compared to baseline 24 months No
Secondary Time to recovery 24 months No
Secondary Disc height at 24 months compared to baseline 24 months No
Secondary Adjacent level deterioration at 24 months compared to baseline 24 months No
Secondary Progressive facet disease at 24 months compared to baseline 24months No
Secondary Displacement or migration of the device 24 months Yes
Secondary Odom's Criteria 24 months No
See also
  Status Clinical Trial Phase
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Enrolling by invitation NCT02171169 - Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures N/A
Not yet recruiting NCT06011551 - HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs N/A
Active, not recruiting NCT01551901 - Luna Interbody System for Fusion Trial N/A
Recruiting NCT05489822 - PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
Active, not recruiting NCT03737461 - Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc Disease (DDD) Unresponsive Phase 2/Phase 3
Enrolling by invitation NCT05536453 - Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine
Completed NCT01972256 - A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures N/A