Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)

Not Applicable

Terminated

• Conditions: Degenerative Disc Disease
• Interventions: Device: Lumbar Artificial Disc; Device: Charite Artificial Disc

• Registration Number: NCT00292292
• Lead Sponsor: SpinalMotion

Brief Summary

The Kineflex Spinal System is no worse than the Charite Spinal System in patients with single level degenerative disc disease at L4/5 or L5/S1.

Detailed Description

The Kineflex disc is a 3-piece modular design consisting of 2 cobalt chrome molybdenum (CCM) end-plates and a fully articulating CCM core. The system is available in 3 foot print sizes.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-15
• Primary Completion: 2009-05
• Disposition First Submitted: 2011-07-19
• Disposition First Submitted QC: 2011-07-19
• Disposition First Posted: 2011-07-22
• Status Verified: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-31
• Last Update Posted: 2013-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 514

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kineflex Lumbar Artificial Disc	Lumbar Artificial Disc	Treatment arm
Charite	Charite Artificial Disc	-

Primary Outcome Measures

Name	Time	Method
Improvement in Oswestry Low Back Pain Disability Score at 24 months compared with baseline; no revision removal, supplemental fixation or device related reoperations and no major adverse event as defined by the study protocol	24 months

Secondary Outcome Measures

Name	Time	Method
Maintenance or improvement in neurologic status	24 months
Pain improvement	24 months
Significant disc height increase	24 months
No displacement or migration of the device	24 months
Time to return to work	24 months
Time to recovery	24 months
Preservation of at least 4 degrees of motion in flexion/extension	24 months

Trial Locations

Locations (21)

Sierra Regional Spine Institute; 🇺🇸 Reno, Nevada, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

Illinois Neuro-Spine Center; 🇺🇸 Aurora, Illinois, United States

Maryland Brain and Spine Center; 🇺🇸 Annapolis, Maryland, United States

Kaiser Oakland Regional Spine Surgery; 🇺🇸 Oakland, California, United States

CORE Orthopaedic Medical Center; 🇺🇸 Encinitas, California, United States

Rocky Mountain Associates in Orthopedic Medicine, P.C.; 🇺🇸 Loveland, Colorado, United States

Tower Orthopedics and Sports Medicine; 🇺🇸 Beverly Hills, California, United States

Orthopedics International Spine; 🇺🇸 Kirkland, Washington, United States

Loma Linda University; 🇺🇸 San Bernardino, California, United States

Spine Institute of Louisiana; 🇺🇸 Shreveport, Louisiana, United States

UCSF Dept. of Orthopaedic Surgery; 🇺🇸 San Francisco, California, United States

Gordon Spine Associates; 🇺🇸 Tyler, Texas, United States

Manhattan Orthopaedics, P.C.; 🇺🇸 New York, New York, United States

Univ. of Pittsburgh Medical Center; 🇺🇸 Pittsburg, Pennsylvania, United States

Orthopaedic Associates, P.A; 🇺🇸 Towson, Maryland, United States

Hamilton Orthopaedic Surgery and Sports Medicine; 🇺🇸 Hamilton, New York, United States

Buffalo Spine Surgery; 🇺🇸 Lockport, New York, United States

Carolina Neurosurgery and Spine Associates; 🇺🇸 Charlotte, North Carolina, United States

Triangle Orthopaedic Associates, P.A.; 🇺🇸 Durham, North Carolina, United States

Texas Back Institute Clinical Research Organization; 🇺🇸 Plano, Texas, United States