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

K2M, Inc.68 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Radiculopathy Myelopathy Spondylosis Herniated Nucleus Pulposus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

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

The intensity of neck pain, right arm pain and left arm pain will be evaluated using a 100 mm VAS. The scale is measured from 0 mm (no pain) to 100 mm (extreme pain). The VAS will be scored at all time points and compared to baseline (pre-operative). A change of 15 mm is considered clinically significant.

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

Secondary Surgeries (Surgical Interventions)

Secondary surgeries will be described and will be classified as follows: * Index Level Revision without Implant Removal: a procedure that adjusts or in any way modifies the original implant configuration without removal of the original implant, e.g., adjusting the position of the implant, or adding supplemental fixation. * Index Level Revision with Implant Removal: a procedure that removes the original implant, with replacement using a new implant or without replacement. * Adjacent Level Surgery: any surgical procedure at a level adjacent to the treated level(s) that does not remove, modify or add any components to the implant configuration. * Other Spine Surgery: surgery at spine level that is not an index or adjacent level. Surgeries unrelated to the spine will not be recorded as secondary surgeries but the adverse effect leading to the surgery will be recorded on an AE form and characterized as an 'inpatient hospitalization.

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

Quality of life (SF-36)

SF-36 survey will be used to calculate overall, mental (MCS) and physical (PCS) component scores at all post-op time-points compared to baseline (pre-operative)

Time frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months

Functional / Economic Impact - Prolo Scale

It is a 10-point scale consisting of only 2 questions evaluating the functional and economic status of patients. Scores 9-10 are considered excellent , scores less than 4 are considered poor.

Time frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months

Neurological function

Neurological function will be assessed pre-operatively and all post-op visits, unscheduled visits to assess an Adverse Event, by evaluating: * Reflexes (0-4) * Signs of myelopathy (Hoffman's, Babinski, Ankle Clonus) * Sensory (light touch, pin prick; impaired/normal) * Motor strength (0-5) Maintenance or improvement in neurological function for this study is defined as: No clinically significant worsening at any post-operative time point that is permanent (compared to baseline or best neurological result post-operatively)

Time frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months

Global Assessment

Subject's self-reported assessment of improvement in their neck/arm problem since treatment. Scored on a 4-pt scale (much better, better, unchanged, worse) at 6, 12, 24 and 60 months.

Time frame: 6 months, 12 months, 24 months and 60 months

Patient satisfaction

This will be based on subject's self-reported response to whether he/she is satisfied with the outcome of his/her neck surgery, scored on a 4-pt scale (strongly agrees, agrees, disagrees, strongly disagrees) at 6, 12, 24 and 60 months.

Time frame: 6 months, 12 months, 24 months and 60 months

Patient treatment success (PTS)

Patients should have met all the of the following criteria: * ≥ 15 point improvement in NDI compared to baseline (pre-operative), * No new or increased permanent, clinically significant neurological deficit compared to baseline (pre-operative), * No device-related surgical intervention (specifically, intra-operative serious device-related AEs (implant or instrument) or conversion to fusion, or device-related secondary surgery at index level).

Time frame: 24 months

Use of NSAIDS and other pain Medications.

Will document duration of prescribed post-operative use of NSAIDS (≤2 weeks, \>2 weeks), and use (frequency and potency) of medications to manage c-spine condition at each follow-up interval compared with pre-operative level of management.

Time frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months

Estimated blood loss

The amount of blood loss over the entire length of the surgery, documented on the Anesthesia Record, will be captured.

Time frame: During Operation

Surgery time

The length of surgical procedure from the initial incision to final closure will be captured from the Anesthesia Record.

Time frame: During Operation

Length of hospital stay

The length of hospital stay from date of admission to date of discharge will be calculated.

Time frame: At discharge, estimated average of 3-6 days after surgery

Surgeon satisfaction with instruments and surgical technique

4-pt scale (very satisfied, satisfied, somewhat unsatisfied, very unsatisfied)

Time frame: At discharge, estimated average of 3-6 days after surgery