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Prospective, Non-Randomized, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics™ M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical Radiculopathy

This is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical radiculopathy with or without cord compression. Some participating sites will enroll just M6-C patients, while others will enroll just ACDF patients.

Patients eligible for study enrollment will present with degenerative cervical radiculopathy requiring surgical intervention, confirmed clinically and radiographically, at one vertebral level from C3 to C7.

A total of 243 subjects will be included at up to 20 sites.

Study Overview

• Status: Unknown
• Conditions: Degenerative Disc Disease; Cervical Radiculopathy
• Intervention / Treatment: Device: M6-C Artificial Cervical Disc; Device: Anterior plate system with corticocancellous allograft bone

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

All study subjects must present with degenerative cervical radiculopathy with or without spinal cord compression, confirmed clinically and radiologically, requiring surgical intervention at a single vertebral level from C3 to C7.

Inclusion Criteria:

1. Diagnosis of degenerative cervical radiculopathy with or without spinal cord compression requiring surgical treatment at one level from C3 to C7 demonstrated by signs and/or symptoms of disc herniation and/or osteophyte formation (e.g. neck and/or arm pain, radiculopathy, etc.) and is confirmed by patient history and radiographic studies (e.g. MRI, CT, x-rays, etc.)
2. Inadequate response to conservative medical care over a period of at least 6 weeks
3. Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
4. Neck or arm pain VAS ≥ 4 on a scale of 0 to 10
5. Willing and able to comply with the requirements of the protocol including follow-up requirements
6. Willing and able to sign a study specific informed consent
7. Skeletally mature and ≥ 18 years old and ≤ 75 years old

Exclusion Criteria:

1. More than one cervical level requiring surgery
2. Previous anterior cervical spine surgery
3. Axial neck pain as the solitary symptom
4. Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine
5. Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels
6. Symptomatic facet arthrosis
7. Less than 4º of motion in flexion/extension at the index level
8. Instability as evidenced by subluxation > 3 mm at the index or adjacent levels as indicated on flexion/extension x-rays
9. Advanced degenerative changes (e.g., spondylosis) at the index vertebral level as evidenced by bridging osteophytes, central disc height < 4mm and/or < 50% of the adjacent normal intervertebral disc, or kyphotic deformity > 11º on neutral x-rays
10. Severe cervical myelopathy (i.e., Nurick's Classification > 2)
11. Active systemic infection or infection at the operative site
12. Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment
13. Metabolic bone disease such as osteoporosis that contradicts spinal surgery (for females over 50 and males over 55 years old, or if the score on the Osteoporosis Self-Assessment Test is < 2, a dual energy x-ray absorptiometry [DEXA scan] of the spine is required; if the bone mineral density T-score in the spine is ≤ -2.5 the patient must be excluded)
14. History of an osteoporotic fracture of the spine, hip or wrist
15. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism
16. Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
17. Known allergy to titanium, stainless steels, polyurethane, polyethylene, or ethylene oxide residuals
18. Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
19. Insulin-dependent type 1 or type 2 diabetes
20. Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion
21. Pregnant, or intend to become pregnant, during the course of the study
22. Severe obesity (Body Mass Index > 40)
23. Physical or mental condition (e.g., psychiatric disorder, senile dementia, Alzheimer's disease, alcohol or drug addiction) that would interfere with patient self-assessment of function, pain or quality of life.
24. Involved in current or pending spinal litigation where permanent disability benefits are being sought
25. Incarcerated at the time of study enrollment
26. Current participation in other investigational study that may impact study outcomes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: M6-C Artificial Cervical Disc	Device: M6-C Artificial Cervical Disc; Total disc replacement
ACTIVE_COMPARATOR: Anterior Cervical Discectomy and Fusion	Device: Anterior plate system with corticocancellous allograft bone; Cervical fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation through 24 months	Evaluate the safety by assessing adverse events and neurological function following implantation with the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)	24 months
Effectiveness Evaluation through 24 months	Evaluate the effectiveness using Neck Disability Index (NDI)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)	Evaluate the Neck and Arm pain VAS, health-related quality of life SF-36, surgery outcomes, patient satisfaction and quantitative and qualitative radiographic assessments	6 weeks, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Spinal Kinetics

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2014
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (ESTIMATE): June 1, 2012

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: neck pain; ACDF; cervical radiculopathy; degenerative disc disease; cervical spine; artificial cervical disc; Spinal Kinetics
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Radiculopathy
• Other Study ID Numbers: CA-C002