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

Degenerative Disc Disease (DDD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00374413
• Other study ID #: Kineflex|C
• 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

Related Conditions & MeSH terms

• Degenerative Disc Disease (DDD)
• Intervertebral Disc Degeneration

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