Trial document




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  DRKS00011029

Trial Description

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Title

RHINE™ Cervical Disc
Prospective Observational Clinical Study

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Trial Acronym

RHINE™ Cervical Disc

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The purpose of this study is to collect data on patient’s clinical and radiographic outcomes (how they are doing) from the cervical (neck) spine surgery utilizing RHINE™ Cervical Disc (“RHINE Disc”). The RHINE Disc is commercially available in Europe. This study is being conducted to gather detailed information in addition to the ongoing monitoring that the Sponsor does on how their products are performing. The RHINE Disc is not experimental. There are no experimental products, procedures, or tests involved in this study; only data on how you do after your surgery will be collected. A total of 166 patients are being recruited for this study from approximately 10 study sites in 6-8 European countries.

Patient’s cervical (neck) spine condition requires treatment that includes the removal of the disc between the vertebral bodies (bones making up the spine) and replacement of the disc with an artificial disc to aid in the stabilization and realignment of your cervical spine. The RHINE Disc is made of medical grade titanium alloy with a central elastomeric core made of polyurethane. The elastomeric core is a compressible core designed to provide shock absorption and controlled, physiologic motion very close to the natural disc.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00011029
  •   2017/04/07
  •   2015/03/19
  •   no
  •   Approved
  •   16077, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   NCT02403453  (Clinical Trails.gov)
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Health Condition or Problem studied

  •   M50.3 -  Other cervical disc degeneration
  •   M54.1 -  Radiculopathy
  •   Reconstruction of the disc from C3 C7 following discectomy at one or two contiguous levels for intractable radiculopathy 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: herniated nucleus pulposus, spondylosis, visible loss of disc height compared to adjacent levels
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Interventions/Observational Groups

  •   Patients who receive a cervical disc replacement with RHINE TM will undergo following assessments and requirements: data collection of pre op + post op, 6-12 weeks and 6,12,24,60 month by a qualified clinician and neurological examination at the visit with standard of care x-ray procedure and subject completes self -assessment questionnaire (satisfaction, pain, disability, quality of life)
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   N/A
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Primary Outcome

The primary objectives of the RHINE™ Cervical Disc (“RHINE Disc”) study are to:
1. Obtain operative data and feedback on surgical instruments and surgical technique.
2. Confirm device performance in terms of clinical and radiographic outcomes.
3. Confirm device performance in terms of safety.
4. 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.

Time frame:
All subjects will be required to return for follow-up visits at 6-12 weeks, and 6, 12, 24 and 60 months post-operatively (the subject exits the study after the 60-month visit or the 60-month window closes).
Follow-up procedures and evaluations, in general, involve the following:
• X-rays as standard of care procedure
• Physical exam by a qualified clinician including neurological examination
• Subject completes self-assessment questionnaires (Global Assessment/Patient satisfaction, pain, disability, quality of life)
• Documentation of current medications used by the subject for management of c-spine symptoms
• Documentation and assessment of any new and ongoing Adverse Events

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
  •   Spain
  •   Sweden
  •   United Kingdom
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/09/28
  •   166
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

All of the following must be met:
1. Skeletally mature and age ≥ 18
2.Patient requires reconstruction of the disc from C3-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 dated within 6 months of the planned date of surgery): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels
3.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
4. VAS score for upper extremity (right or left) pain ≥ 20 (1-100)
5. NDI score ≥ 30% (raw score ≥ 15/50)
6. Willing and able to comply with the protocol requirements including follow-up visit schedule
7. Willing and able to sign study specific informed consent

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Exclusion Criteria

None of the following must be present:
1. More than two cervical levels requiring surgery, or has two levels requiring surgery that are not adjacent.
2. Previous surgical intervention at the target level(s)
3. 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
4. Significant kyphotic deformity (> 5 degrees) at a single level or significant reversal of lordosis (not corrected with extension)
5. Fused level adjacent to a level to be treated
6. Axial neck pain is the patient's solitary symptom
7. Severe pathology of the facet joints of the involved vertebral bodies
8. Previous diagnosis of osteopenia or osteomalacia
9. Has any of the following risk factors that may be associated with a diagnosis of osteoporosis. (if Yes, to any, a DEXA-Scan is required): Postmenopausal, non-black female > 60 years of age and weights <63,5 kg, Postmenopausal female who has sustained a non-traumatic hip,-spine - or wrist fracture, Male > 70 years, Male > 60 years who has sustained a non-traumatic hip or spine fracture. I DEXA is indicated and BMD is <-2.5, than the patient is excluded from the study.
10. Spinal metastases
11.Extreme obesity (BMI ≥ 40)
12. Overt or active bacterial infection, either local or systemic
13. Severe insulin dependent diabetes
14. Chronic or acute renal failure or prior history of renal disease
15. Fever (temp > 38.3° C oral) at the time of surgery
16. Documented allergy or intolerance to titanium or polyurethane
17. Reported concomitant conditions requiring: daily, high-dose oral and/or inhaled steroids
18. 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
19. Any medical condition that may result in patient death prior to study completion, e.g., unstable cardiac disease, active malignancy
20. History of an endocrine or metabolic disorder known to affect osteogenesis
21. Active immunosuppressive disorder that may predispose patient to infection
22. Participating in or planning to participate in another clinical study that might influence the treatment outcomes or ability to comply with the study requirements
23. Member of a vulnerable population such as, mentally incompetent, prisoner
24. 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.
25. History or suspicion of substance abuse or currently undergoing substance abuse treatment
26. In the judgment of the Investigator, patient is not likely to be able to fulfill the requirements of the study.

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Addresses

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    • K2M
    • 600 Hope Parkway
    • 20175  Leesburg
    • United States
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    • Doktor der Medizin, HauptprüferHessing-Stiftung
    • Ardeshiri  Ardavan 
    • Hessingstraße 17
    • 86799   Augsburg,
    • Germany
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    • SD Spine Consult
    • Ms.  Sabine Claudia  Dilger 
    • Mugerenstrasse 31 C
    • 6330  Cham
    • Switzerland
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Sources of Monetary or Material Support

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    • K2M
    • 600 Hope Parkway
    • 20175  Leesburg
    • United States
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.