RHINE™ Cervical Disc Clinical Study: A Prospective Observational Study for Patients Requiring 1-2 Level C-spine Surgery

NCT02403453 | Terminated

• 1 other identifier: CA-009
• Study Type: observational
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Prospective, open label, multi-center observational study of patients requiring surgical treatment at one or two (contiguous) cervical spine levels. The primary objectives of the RHINE Cervical Disc study are to: obtain operative data and feedback on surgical instruments and surgical technique; confirm device performance in terms of clinical and radiographic outcomes; confirm device performance in terms of safety and to collect original data to be compared to published reports of the performance of comparable motion-sparing devices, as well as clinical outcomes of fusion devices.

Conditions

Radiculopathy; Myelopathy; Spondylosis; Herniated Nucleus Pulposus

Keywords

Radiculopathy; Myelopathy; Spondylosis; Herniated Nucleus Pulposus; C3-C7; Osteophytes; Neurological deficit

Outcome Measures

Primary Outcomes (3)

• Neck Disability Index (NDI) change from baseline

  Evaluation of the change in function will be scored using the Neck Disability Index (NDI) at all time points compared to baseline (pre-operative). NDI is a subject-completed, condition-specific functional status questionnaire with 10 questions. Each question is scored from 0 to 5, summed to a total and multiplied by 2 to get a score from 0 to 100. A 15 point change in NDI score compared with baseline (pre-operative score) will be used as the measure for a clinically significant change.

  Pre-operative, 6 months, 12 months, 24 months and 60 months

• Radiographic Outcomes

  Anteroposterior \& Lateral ( or MRI at Pre-operative ) and Flexion and Extension x-rays will be taken at all time points. An independent radiologist will review and assess all radiographs including: range of motion, translation, intervertebral height, device height, device positioning/migration, heterotopic ossification and adjacent segment degeneration.

  Pre-operative, 6-12 weeks, 6 months, 12 months, 24 months and 60 months

• Number of Patients with Adverse Events (AEs)

  AEs will be monitored throughout the study and characterized by seriousness, severity and relationship to the device and procedure, at a minimum.

  Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months

Secondary Outcomes (13)

• Pain: Neck, Right Arm, Left Arm, Worst arm Visual analog Scale Change form Baseline

  Pre-operative, 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months

• Secondary Surgeries (Surgical Interventions)

  Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months and 60 months

• Quality of life (SF-36)

  Pre-operative, 6 months, 12 months, 24 months annd 60 months

• Functional / Economic Impact - Prolo Scale

  Pre-operative, 6 months, 12 months, 24 months annd 60 months

• Neurological function

  Pre-operative, 6 months, 12 months, 24 months annd 60 months

Interventions

Rhine Cervical Disc DEVICE

RHINE Cervical Disc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for the study enrollment will be skeletally mature patients undergoing reconstruction of the disc from C3 to C7 following discectomy at one or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. Patients should have failed at least 6 weeks of non-operative treatment or demonstrated progressive signs or symptoms despite non-operative treatment prior to implantation.

You may qualify if:

• The patient requires reconstruction of the disc from C3 to C7 following discectomy at 1 or 2 (contiguous) levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels.
• The patient has failed at least 6 weeks of non-operative treatment or demonstrated progressive signs or symptoms despite non-operative treatment prior to implantation.
• Self-reports a pre-operative upper extremity (right or left) VAS pain score ≥ 20 (0-100).
• Self-reports pre-operative NDI score ≥ 30% (raw score of ≥ 15/50).
• Willing and able to comply with the protocol requirements including follow-up visit schedule.
• Willing and able to sign a study specific informed consent.

You may not qualify if:

• More than two cervical levels requiring surgery, or has two levels requiring surgery that are not adjacent.
• Previous surgical intervention at the target level(s)
• Any of the following at the target level(s):
• Significant cervical anatomical deformity, e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
• Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes characterized by any of the following: bridging osteophytes, marked reduction or absence of motion (\< 2 degrees change from flexion to extension), collapse of the intervertebral disc space of greater than 50% of its normal height (compared to adjacent levels)
• Radiographic signs of subluxation \> 3.5 mm
• Angulation of the disc space more than 11 degrees greater than adjacent segments
• Significant kyphotic deformity (\> 5 degrees) at a single level or significant reversal of lordosis (not corrected with extension)
• Fused level adjacent to a level to be treated
• Axial neck pain is the patient's solitary symptom
• Severe pathology of the facet joints of the involved vertebral bodies
• Previous diagnosis of osteopenia or osteomalacia
• Has any of the following risk factors that may be associated with a diagnosis of osteoporosis.
• Spinal metastases
• Extreme obesity (BMI ≥ 40)

Sponsors & Collaborators

• K2M, Inc.: lead
• Stryker Nordic: collaborator

Related Publications (7)

• MacDermid JC, Walton DM, Avery S, Blanchard A, Etruw E, McAlpine C, Goldsmith CH. Measurement properties of the neck disability index: a systematic review. J Orthop Sports Phys Ther. 2009 May;39(5):400-17. doi: 10.2519/jospt.2009.2930.

  PMID: 19521015 BACKGROUND

• Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.

  PMID: 6450426 BACKGROUND

• Hagg O, Fritzell P, Oden A, Nordwall A; Swedish Lumbar Spine Study Group. Simplifying outcome measurement: evaluation of instruments for measuring outcome after fusion surgery for chronic low back pain. Spine (Phila Pa 1976). 2002 Jun 1;27(11):1213-22. doi: 10.1097/00007632-200206010-00014.

  PMID: 12045520 BACKGROUND

• Mehren C, Suchomel P, Grochulla F, Barsa P, Sourkova P, Hradil J, Korge A, Mayer HM. Heterotopic ossification in total cervical artificial disc replacement. Spine (Phila Pa 1976). 2006 Nov 15;31(24):2802-6. doi: 10.1097/01.brs.0000245852.70594.d5.

  PMID: 17108833 BACKGROUND

• McAfee PC, Cunningham BW, Devine J, Williams E, Yu-Yahiro J. Classification of heterotopic ossification (HO) in artificial disk replacement. J Spinal Disord Tech. 2003 Aug;16(4):384-9. doi: 10.1097/00024720-200308000-00010.

  PMID: 12902954 BACKGROUND

• Beaurain J, Bernard P, Dufour T, Fuentes JM, Hovorka I, Huppert J, Steib JP, Vital JM, Aubourg L, Vila T. Intermediate clinical and radiological results of cervical TDR (Mobi-C) with up to 2 years of follow-up. Eur Spine J. 2009 Jun;18(6):841-50. doi: 10.1007/s00586-009-1017-6. Epub 2009 May 12.

  PMID: 19434431 BACKGROUND

• Geisler FH, Blumenthal SL, Guyer RD, McAfee PC, Regan JJ, Johnson JP, Mullin B. Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charite intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004. J Neurosurg Spine. 2004 Sep;1(2):143-54. doi: 10.3171/spi.2004.1.2.0143.

  PMID: 15346999 BACKGROUND

MeSH Terms

Conditions

Radiculopathy; Spinal Cord Diseases; Spondylosis; Osteophyte; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Central Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Exostoses; Hyperostosis; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 31, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10