AzTrials
AzTrials

RadiculopathyNCT02403453

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

An observational study of Radiculopathy and Myelopathy, run by K2M, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Radiculopathy, Myelopathy, Spondylosis
What is being tested?
Rhine Cervical Disc
Type of treatment
Medical device
How many people
68 participants
Where
No sites listed yet
Study dates
Jan 2016to Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 30Show fewer
  • 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.

About this study

Official title: RHINE™ Cervical Disc Clinical Study

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.

Read the 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.

Being tested
Rhine Cervical Disc
Keywords
Radiculopathy, Myelopathy, Spondylosis, Herniated Nucleus Pulposus, C3-C7, Osteophytes, Neurological deficit
Medical subject headings
Radiculopathy, Spinal Cord Diseases, Spondylosis, Osteophyte, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rhine Cervical DiscDevice

    RHINE Cervical Disc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (13)

  1. 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.

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

  2. 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.

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

  3. 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)

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

  4. 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.

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

  5. 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)

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

  6. 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.

    Measured: 6 months, 12 months, 24 months and 60 months

  7. 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.

    Measured: 6 months, 12 months, 24 months and 60 months

  8. 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).

    Measured: 24 months

  9. 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.

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

  10. Estimated blood loss

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

    Measured: During Operation

  11. Surgery time

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

    Measured: During Operation

  12. Length of hospital stay

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

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

  13. Surgeon satisfaction with instruments and surgical technique

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionMar 2023
  4. Study completionMar 2023

Why it stopped: Stryker has made the decision to remove the Rhine Cervical Disc Replacement from their product portfolio. Stryker is not aware of any safety or effectiveness concerns and this decision is not related to poor patient outcomes or known device failures.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02403453
Sponsor's protocol ID
CA-009
Status last verified
Oct 2023
First submitted
19 Mar 2015
Last updated
25 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19521015

  • 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.

    PubMed 6450426

  • 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.

    PubMed 12045520

  • 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.

    PubMed 17108833

  • 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.

    PubMed 12902954

  • 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.

    PubMed 19434431

  • 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.

    PubMed 15346999

Questions about this trial

What is this clinical trial studying?

An observational study of Radiculopathy and Myelopathy, run by K2M, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Stryker has made the decision to remove the Rhine Cervical Disc Replacement from their product portfolio. Stryker is not aware of any safety or effectiveness concerns and this decision is not related to poor patient outcomes or known device failures.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck Disability Index (NDI) change from baseline (time frame: Pre-operative, 6 months, 12 months, 24 months and 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02403453, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in