Clinical trial NCT02403453: RHINE™ Cervical Disc Clinical Study: A Prospective Observational Study for Patients Requiring 1-2 Level C-spine Surgery
Official title: RHINE™ Cervical Disc Clinical Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Radiculopathy
Myelopathy
Spondylosis
Herniated Nucleus Pulposus
Keywords: Radiculopathy
Myelopathy
Spondylosis
Herniated Nucleus Pulposus
C3-C7
Osteophytes
Neurological deficit
Lead sponsor: K2M, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stryker Nordic
First posted: 2015-03-31
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: A Prospective, open label, multi-center observational study of patients requiring surgical treatment at one or two (contiguous) cervical spine levels ( C3-C7). 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. Device- and procedure-related adverse events, serious adverse events, and secondary surgeries will be monitored throughout. AEs will be characterized by severity, seriousness and relationship to device. Investigator reports of serious adverse events and any AE trends will be reviewed by a medical monitor.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)
* Overt or active bacterial infection, either local or systemic
* Severe insulin dependent diabetes
* Chronic or acute renal failure or prior history of renal disease
* Fever (temp \> 38.3° C oral) at the time of surgery
* Documented allergy or intolerance to titanium or polyurethane
* Reported concomitant conditions requiring daily, high-dose oral and/or inhaled steroids.
* Any medical condition that may interfere with the postoperative management program or preclude meaningful patient self-assessments, e.g., advanced emphysema, progressive neurological disease, or Alzheimer's disease
* Any medical condition that may result in patient death prior to study completion, e.g., unstable cardiac disease, active malignancy
* History of an endocrine or metabolic disorder known to affect osteogenesis
* Active immunosuppressive disorder that may predispose patient to infection
* Participating in or planning to participate in another clinical study that might influence the treatment outcomes or ability to comply with the study requirements
* Member of a vulnerable population such as, mentally incompetent, prisoner
* Pregnant, nursing, considering becoming pregnant during the study, or is of childbearing potential and unwilling to use an accepted form of birth control during the study.
* History or suspicion of substance abuse or currently undergoing substance abuse treatment
* In the judgment of the Investigator, patient is not likely to be able to fulfill the requirements of the study.

Primary outcomes:
measure: Neck Disability Index (NDI) change from baseline
timeFrame: Pre-operative, 6 months, 12 months, 24 months and 60 months
measure: Radiographic Outcomes
timeFrame: Pre-operative, 6-12 weeks, 6 months, 12 months, 24 months and 60 months
measure: Number of Patients with Adverse Events (AEs)
timeFrame: Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months
Secondary outcomes:
measure: Pain: Neck, Right Arm, Left Arm, Worst arm Visual analog Scale Change form Baseline
timeFrame: Pre-operative, 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months
measure: Secondary Surgeries (Surgical Interventions)
timeFrame: Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months and 60 months
measure: Quality of life (SF-36)
timeFrame: Pre-operative, 6 months, 12 months, 24 months annd 60 months
measure: Functional / Economic Impact - Prolo Scale
timeFrame: Pre-operative, 6 months, 12 months, 24 months annd 60 months
measure: Neurological function
timeFrame: Pre-operative, 6 months, 12 months, 24 months annd 60 months
measure: Global Assessment
timeFrame: 6 months, 12 months, 24 months and 60 months
measure: Patient satisfaction
timeFrame: 6 months, 12 months, 24 months and 60 months
measure: Patient treatment success (PTS)
timeFrame: 24 months
measure: Use of NSAIDS and other pain Medications.
timeFrame: Pre-operative, 6 months, 12 months, 24 months annd 60 months
measure: Estimated blood loss
timeFrame: During Operation
measure: Surgery time
timeFrame: During Operation
measure: Length of hospital stay
timeFrame: At discharge, estimated average of 3-6 days after surgery
measure: Surgeon satisfaction with instruments and surgical technique
timeFrame: At discharge, estimated average of 3-6 days after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.