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

DePuy Spine500 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

500

Conditions

Cervical Degenerative Disc Disease

Interventions

Cervical TDRDEVICE

Cervical total disc replacement using a DISCOVER Artificial Cervical Disc.

ACDF with plateDEVICE

Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (32)

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 24 months

Neurological Component of Success

no new clinically significant permanent abnormalities in neurological function

Time frame: 24 months

Subsequent Secondary Surgery Component of Success

no subsequent secondary surgical intervention at the index level

Time frame: 24 months

Device-Related SAE Component of Success

no device related serious adverse events

Time frame: 24 months

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.

Time frame: 24 months

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.

Data from ClinicalTrials.gov

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Olympia Medical Center

Beverly Hills, California, United States

Sutter Medical Center

Sacramento, California, United States

Rocky Mountain Associates in Orthopedic Medicine, PC

Loveland, Colorado, United States

Yale University

New Haven, Connecticut, United States

Florida Orthopaedic Institute

Tampa, Florida, United States

Emory Orthopaedics and Spine Center

Atlanta, Georgia, United States

Rush University/Midwest Orthopaedics

Chicago, Illinois, United States

Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Johnson County Spine

Overland Park, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

...and 22 more locations

Time frame: 24 months

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.

Time frame: 24 months

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.

Time frame: 24 months

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.

Time frame: 24 months

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.

Time frame: 24 months

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.

Time frame: 24 months

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)

Time frame: 24 months

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)

Time frame: 24 months

Work Status Assessment

Time frame: 24 months

Return to Work

Estimated Proportion of Subjects Returning to Work

Time frame: 24 months

Activity

Clinical Assessment of Activity

Time frame: 24 months

Subject Satisfaction

Subject Satisfaction (Would you have this procedure again?)

Time frame: 24 months

Global Cervical Range of Motion - Change From Baseline

Time frame: 24 months

Average Radiographic Disc Height (mm) - Change From Post-op

Time frame: 24 months