Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)

Cervical Degenerative Disc Disease Clinical Trial

Official title:

A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432159
• Other study ID #: 06-DISCOVER
• Status: Completed
• Phase: N/A
• First received: February 5, 2007
• Last updated: September 19, 2017
• Start date: July 1, 2006
• Est. completion date: May 1, 2016

Study information

• Verified date: September 2017
• Source: DePuy Spine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or SLIM-LOC™ (cervical fusion) to determine the safety and efficacy at 2 years post operative. Follow-up on patients treated with total disc replacement will be continued to 5 years post operative.

Description:

This study is designed as a multicenter, prospective, randomized, controlled trial. Subjects will be stratified by the number of levels to be treated then assigned treatment in a randomized 1:1 ratio. Participants in the treatment group will undergo cervical total disc replacement with the DISCOVER Artificial Cervical Disc. Participants in the control group will undergo anterior cervical discectomy and fusion with the SLIM-LOC™ Anterior Cervical Plate System with a cortical or cortico-cancellous allograft spacer. Follow-up visits will occur at 2 weeks, 3 and 6 months and 1, and 2 years for all randomized subjects. Subjects that received the control treatment will complete their required study participation at 2 years post operative and subjects assigned the Discover treatment will complete their participation at 5 years post operative. Follow-up for the Discover treatment group will be via a telephone administered questionnaire at 3, 4 and 5 years post operative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 1, 2016
• Est. primary completion date: May 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as (a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or (b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement

• Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management

• Moderate Neck Disability Index (NDI) score

• Able to give informed consent for study participation

• Able and willing to return for all follow-up visits

Key Exclusion Criteria:

• Significant cervical degenerative disc disease

• Prior fusion procedure at any level(s) (C1-T1)

• Marked cervical instability on lateral or flexion/extension radiographs

• Presence of systemic infection or infection at the surgical site

• Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing

• History of alcohol and/or drug abuse

• Any known allergy to a metal alloy or polyethylene

• Morbid obesity

• Any significant general illness (e.g., metastatic cancer, HIV)

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• Cervical TDR
Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.
• ACDF with plate
Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.

Locations

Country	Name	City	State
Australia	Pacific Private Clinic	Queensland
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory Orthopaedics and Spine Center	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Olympia Medical Center	Beverly Hills	California
United States	Carolina Neurosurgery & Spine Associates	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern Medical Faculty Foundation	Chicago	Illinois
United States	Rush University/Midwest Orthopaedics	Chicago	Illinois
United States	North Texas Spine Care at Baylor Health	Dallas	Texas
United States	Triangle Orthopaedic Associates	Durham	North Carolina
United States	Neurospine Institute	Eugene	Oregon
United States	Southern NY Neurosurgical Group	Johnson City	New York
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Center for Diseases and Surgery of the Spine	Las Vegas	Nevada
United States	University of Kentucky	Lexington	Kentucky
United States	Rocky Mountain Associates in Orthopedic Medicine, PC	Loveland	Colorado
United States	Twin Cities Spine	Minneapolis	Minnesota
United States	St. Patrick Hospital Neurological Associates	Missoula	Montana
United States	Yale University	New Haven	Connecticut
United States	University of Medicine and Dentistry of New Jersey	Newark	New Jersey
United States	Boston Spine Group	Newton	Massachusetts
United States	Nebraska Spine Center, LLC	Omaha	Nebraska
United States	Johnson County Spine	Overland Park	Kansas
United States	Texas Back Institute	Plano	Texas
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Sutter Medical Center	Sacramento	California
United States	University of Utah	Salt Lake City	Utah
United States	St. John's Regional Medical Center	Springfield	Missouri
United States	Upstate Medical College/SUNY	Syracuse	New York
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Spine

Countries where clinical trial is conducted

United States,  Australia,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Success	Subject must show 15 point improvement in the Neck Disability Index from baseline to 24 months post operative as well as have no device related SAE, Secondary Surgical Interventions at the index level or any new permanent neurological deterioration.	24 months
Secondary	NDI Success	15 point improvement in NDI. NDI has a max score of 50, which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.	24 months
Secondary	Neurological Component of Success	no new clinically significant permanent abnormalities in neurological function	24 months
Secondary	Subsequent Secondary Surgery Component of Success	no subsequent secondary surgical intervention at the index level	24 months
Secondary	Device-Related SAE Component of Success	no device related serious adverse events	24 months
Secondary	NDI - Change From Baseline	Change from baseline of the Neck Disability Index. NDI has a minimum score of 0 (no disability) and a maximum score of 50 (complete disability) , which is calculated based on the 6 answers to each of the 10 questions. Each answer within a question is given a numerical value 0 to 5.	24 months
Secondary	Neck Pain VAS Scores - Change From Baseline	Change from baseline of the Neck Pain VAS Scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their neck.	24 months
Secondary	Maximum Arm Pain VAS - Change From Baseline	Change from baseline in maximum value of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.	24 months
Secondary	Average Arm Pain VAS - Change From Baseline	Change from baseline in average of the left and right arm VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their arm.	24 months
Secondary	Maximum Shoulder Pain VAS - Change From Baseline	Change from baseline in Maximum value of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.	24 months
Secondary	Average Shoulder Pain VAS - Change From Baseline	Change from baseline in Average of the left and right shoulder VAS scores. VAS is a 100-mm visual analog scale used to assess pain. It asks the subject to place a vertical mark on a 100-mm horizontal line, with 'No pain' listed on the left (at 0 mm) and 'Very severe pain' labeled on the right (at 100 mm). The subject is instructed to indicate the amount of pain they feel in their shoulder.	24 months
Secondary	Dysphagia Disability Index - Change From Baseline	Change from baseline in Dysphagia Disability Index (DDI). The DDI is designed to evaluate dysphagia, difficulty in swallowing, using a 25-item questionnaire. Responses from the questionnaire were scored as "always" 4, "sometimes" 2, or "never" 0, and summed to provide a total score (range 0-100). Higher DDI scores suggest greater subjective signs of dysphagia.	24 months
Secondary	SF-36 - Physical Composite Scores (PCS) - Change From Baseline	Change from baseline in Quality of Life - Physical Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)	24 months
Secondary	SF-36 - Mental Composite Scores (MCS) - Change From Baseline	Change from baseline in Quality of Life - Mental Composite Scores. SF-36 is based on units on a scale; where 0 is severe disability and 100 is no disability. The scores are scaled (based on weighted sum of the questions)	24 months
Secondary	Work Status Assessment		24 months
Secondary	Return to Work	Estimated Proportion of Subjects Returning to Work	24 months
Secondary	Activity	Clinical Assessment of Activity	24 months
Secondary	Subject Satisfaction	Subject Satisfaction (Would you have this procedure again?)	24 months
Secondary	Global Cervical Range of Motion - Change From Baseline		24 months
Secondary	Average Radiographic Disc Height (mm) - Change From Post-op		24 months