Restore CLINICAL TRIAL

NCT01609374 | Unknown DMC

• 1 other identifier: CA-C002
• Study Type: interventional
• Target: 258
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Radiculopathy; Degenerative Disc Disease

Keywords

Spinal Kinetics; artificial cervical disc; cervical radiculopathy; ACDF; neck pain; cervical spine; degenerative disc disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF)

  6 weeks, 3 months, 6 months, 12 months, 24 months

Study Arms (2)

M6-C Artificial Cervical Disc

EXPERIMENTAL

Device: M6-C Artificial Cervical Disc

Anterior Cervical Discectomy and Fusion

ACTIVE COMPARATOR

Device: Anterior plate system with corticocancellous allograft bone

Interventions

M6-C Artificial Cervical Disc DEVICE

Total disc replacement

M6-C Artificial Cervical Disc

Anterior plate system with corticocancellous allograft bone DEVICE

Cervical fusion

Anterior Cervical Discectomy and Fusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• Inadequate response to conservative medical care over a period of at least 6 weeks
• Neck Disability Index score of ≥ 30% (raw score of ≥ 15/50)
• Neck or arm pain VAS ≥ 4 on a scale of 0 to 10
• Willing and able to comply with the requirements of the protocol including follow-up requirements
• Willing and able to sign a study specific informed consent
• Skeletally mature and ≥ 18 years old and ≤ 75 years old

You may not qualify if:

• More than one cervical level requiring surgery
• Previous anterior cervical spine surgery
• Axial neck pain as the solitary symptom
• Previous posterior cervical spine surgery (e.g., posterior element decompression) that destabilizes the cervical spine
• Advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative or adjacent levels
• Symptomatic facet arthrosis
• Less than 4º of motion in flexion/extension at the index level
• Instability as evidenced by subluxation \> 3 mm at the index or adjacent levels as indicated on flexion/extension x-rays
• 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
• Severe cervical myelopathy (i.e., Nurick's Classification \> 2)
• Active systemic infection or infection at the operative site
• Co-morbid medical conditions of the spine or upper extremities that may affect the cervical spine neurological and/or pain assessment
• 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)
• History of an osteoporotic fracture of the spine, hip or wrist
• History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism

Sponsors & Collaborators

• Spinal Kinetics: lead

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Degeneration; Neck Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: since the study is concurrently controlled, masking is not possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: non-randomized, concurrent ACDF control

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: June 1, 2012
• Study Start: May 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-03