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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: RHINE™ Cervical Disc Clinical Study

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 Summary: 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.
Sponsor: K2M, Inc.

Current Primary Outcome:

  • Neck Disability Index (NDI) change from baseline [ Time Frame: Pre-operative, 6 months, 12 months, 24 months and 60 months ]
    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.
  • Radiographic Outcomes [ Time Frame: Pre-operative, 6-12 weeks, 6 months, 12 months, 24 months and 60 months ]
    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.
  • Number of Patients with Adverse Events (AEs) [ Time Frame: Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months ]
    AEs will be monitored throughout the study and characterized by seriousness, severity and relationship to the device and procedure, at a minimum.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain: Neck, Right Arm, Left Arm, Worst arm Visual analog Scale Change form Baseline [ Time Frame: Pre-operative, 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months ]
    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.
  • Secondary Surgeries (Surgical Interventions) [ Time Frame: Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months and 60 months ]

    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.

  • Quality of life (SF-36) [ Time Frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months ]
    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)
  • Functional / Economic Impact - Prolo Scale [ Time Frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months ]
    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.
  • Neurological function [ Time Frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months ]

    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)

  • Global Assessment [ Time Frame: 6 months, 12 months, 24 months and 60 months ]
    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.
  • Patient satisfaction [ Time Frame: 6 months, 12 months, 24 months and 60 months ]
    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.
  • Patient treatment success (PTS) [ Time Frame: 24 months ]

    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).
  • Use of NSAIDS and other pain Medications. [ Time Frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months ]
    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 managemen

    Original Secondary Outcome:

    • Pain: Neck, Right Arm, Left Arm, Worst arm Visual analog Scale Change form Baseline [ Time Frame: Pre-operative, 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months ]
      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.
    • Secondary Surgeries (Surgical Interventions) [ Time Frame: Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months and 60 months ]

      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.

    • Quality of life (SF-36) [ Time Frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months ]
      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)
    • Functional / Economic Impact - Prolo Scale [ Time Frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months ]
      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.
    • Neurological function [ Time Frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months ]

      Neurological function will be assessed pre-operatively and all post-op visits, including unscheduled visits to assess an Adverse Event, by evaluation of:

      • Reflexes (0-4)
      • Babinski, Ankle Clonus: (absent present)
      • 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)
    • Global Assessment [ Time Frame: 6 months, 12 months, 24 months and 60 months ]
      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.
    • Patient satisfaction [ Time Frame: 6 months, 12 months, 24 months and 60 months ]
      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.
    • Patient treatment success (PTS) [ Time Frame: 24 months ]

      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).
    • Use of NSAIDS and other pain Medications. [ Time Frame: Pre-operative, 6 months, 12 months, 24 months annd 60 months ]
      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.
    • Estimated bloo

      Information By: K2M, Inc.

      Dates:
      Date Received: March 19, 2015
      Date Started: January 2016
      Date Completion: August 2021
      Last Updated: January 28, 2016
      Last Verified: January 2016