LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE

NCT00389597 | Completed Results DMC

• 1 other identifier: LDR-001
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 24

Brief Summary

The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device. The primary objective of the study is to evaluate the overall success rate of the investigational device as compared to the control in the treatment of patients with symptomatic DDD with radiculopathy or myeloradiculopathy at one or two adjacent levels. Patients should be without prior cervical fusion between C3 and C7 and unresponsive to non-operative conservative treatment for six weeks after symptom onset or have the presence of progressive symptoms or signs of nerve/spinal cord compression despite continued non-operative conservative treatment.

Conditions

Degenerative Disc Disease

Keywords

degenerative disc disease; cervical arthroplasty; Mobi C; multilevel; anterior cervical discectomy and fusion

Outcome Measures

Primary Outcomes (1)

• Composite Definition of Study Success

  An individual subject in either treatment group was considered a success if the following criteria were met at 24 months: * Improvement in Neck Disability Index of at least 15/50 points in subjects with baseline Neck Disability Index scores of \>= 30/50 points, or a 50% improvement in subjects with a baseline Neck Disability Score score of \<30/50 where the Neck Disability Index is a measure designed to enable the physician to understand how much a subject's neck pain has affected his ability to manage everyday activities. * No study failures due to secondary surgical interventions at the index level * Absence of major complications defined as radiographic failure, neurologic failure, or failure by adverse event as adjudicated by the CEC

  2 Years

Study Arms (2)

1 Level

EXPERIMENTAL

Cervical artificial disc (investigational device) at 1 level compared with control procedure (ACDF) at one level

Device: Cervical Artificial Disc

2 Level

EXPERIMENTAL

Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels

Device: Cervical Artificial Disc

Interventions

Cervical Artificial Disc DEVICE

Cervical artificial disc mechanical device

1 Level; 2 Level

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-69 years.
• Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:
• Neck and/or arm pain (at least 30mm on the 100mm VAS scale).
• Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.
• Abnormal sensation including hyperesthesia or hypoesthesia; and/or
• Abnormal reflexes
• Symptomatic at one or two adjacent levels from C3 to C7;
• Radiographically determined pathology at one or two adjacent level(s) to be treated correlating to primary symptoms including at least one of the following:
• Decreased disc height on radiography, CT, or MRI in comparison to a normal adjacent disc.
• Degenerative spondylosis on CT or MRI.
• Disc herniation on CT or MRI;
• Neck Disability Index Score of ≥15/50 or ≥30%;
• Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and/or analgesics) for:
• Approximately six weeks from radiculopathy or myeloradiculopathy symptom onset; or
• Have the presence of progressive symptoms or signs of nerve root/spinal cord compression despite continued non-operative conservative treatment.

You may not qualify if:

• Reported to have an active systemic infection or infection at the operative site;
• Reported to have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C;
• More than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic "spontaneous" fusions;
• Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury;
• Reported to have had any prior spine surgery at the operative level;
• Reported to have had prior cervical fusion procedure at any level;
• Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention;
• Disc height less than 3mm as measured from the center of the disc in a neutral position and disc height less than 20% of the anterior-posterior width of the inferior vertebral body;
• Radiographic confirmation of severe facet joint disease or degeneration;
• Note: Not a complete listing

Sponsors & Collaborators

• LDR Spine USA: lead

Study Sites (24)

Texas Back Institute-West

Phoenix, Arizona, 85015, United States

Location

Southern California Institute of Neurological Surgery

Escondido, California, 92122, United States

Location

Massoudi & Jackson Neurosurgical Association

Laguna Hills, California, 92653, United States

Location

Memorial Orthopaedic Surgical Group

Long Beach, California, 90806, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

University of California- Davis Medical Center

Sacramento, California, 95817, United States

Location

Spine Institute at St. John's Health Center

Santa Monica, California, 90404, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Panorama Orthopedics and Spine Care

Golden, Colorado, 80401, United States

Location

Southeastern Clinical Research

Orlando, Florida, 32804, United States

Location

Orthopaedics North East

Fort Wayne, Indiana, 46825, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

GBMC Healthcare

Baltimore, Maryland, 21204, United States

Location

University Neurologic Systems

Detroit, Michigan, 48201, United States

Location

St. Mary's of Saginaw Field Neurosciences Institute

Saginaw, Michigan, 48604, United States

Location

Simmons Orthopaedics and Spine Associates

Buffalo, New York, 14201, United States

Location

Orthopedic Spine Care of Long Island

Melville, New York, 11747, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oklahoma Spine & Brain Institute

Tulsa, Oklahoma, 74132, United States

Location

Austin Brain and Spine

Austin, Texas, 78701, United States

Location

Foundation Surgical Hospital

Houston, Texas, 77401, United States

Location

West Texas Spine

Odessa, Texas, 79761, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

Texas Spine and Joint Hospital

Tyler, Texas, 75701, United States

Location

Related Publications (6)

• Hisey MS, Bae HW, Davis R, Gaede S, Hoffman G, Kim K, Nunley PD, Peterson D, Rashbaum R, Stokes J. Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine. Int J Spine Surg. 2014 Dec 1;8:7. doi: 10.14444/1007. eCollection 2014.

  PMID: 25694918 RESULT

• Davis RJ, Kim KD, Hisey MS, Hoffman GA, Bae HW, Gaede SE, Rashbaum RF, Nunley PD, Peterson DL, Stokes JK. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. 2013 Nov;19(5):532-45. doi: 10.3171/2013.6.SPINE12527. Epub 2013 Sep 6.

  PMID: 24010901 RESULT

• Radcliff K, Davis RJ, Hisey MS, Nunley PD, Hoffman GA, Jackson RJ, Bae HW, Albert T, Coric D. Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C(c) Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J Spine Surg. 2017 Nov 28;11(4):31. doi: 10.14444/4031. eCollection 2017.

  PMID: 29372135 DERIVED

• Radcliff K, Coric D, Albert T. Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. 2016 Aug;25(2):213-24. doi: 10.3171/2015.12.SPINE15824. Epub 2016 Mar 25.

  PMID: 27015130 DERIVED

• Jackson RJ, Davis RJ, Hoffman GA, Bae HW, Hisey MS, Kim KD, Gaede SE, Nunley PD. Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up. J Neurosurg Spine. 2016 May;24(5):734-45. doi: 10.3171/2015.8.SPINE15219. Epub 2016 Jan 22.

  PMID: 26799118 DERIVED

• Davis RJ, Nunley PD, Kim KD, Hisey MS, Jackson RJ, Bae HW, Hoffman GA, Gaede SE, Danielson GO 3rd, Gordon C, Stone MB. Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. J Neurosurg Spine. 2015 Jan;22(1):15-25. doi: 10.3171/2014.7.SPINE13953.

  PMID: 25380538 DERIVED

Related Links

• FDA Approval 2 Level
• FDA Approval 1 Level

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Noah Bartsch, VP, Clinical,Regulatory,Quality
• Organization: LDR Spine

noah.bartsch@ldrspine.com

512-344-3319

Study Officials

• Ralph Rashbaum, MD

  Texas Back Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: April 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: November 1, 2015
• Last Updated: December 11, 2017
• Results First Posted: May 1, 2014

Record last verified: 2017-11

Locations

US (24)