RHINE™ Cervical Disc Prospective Observational Clinical Study

• Conditions: 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; M50.3; M54.1; Other cervical disc degeneration; Radiculopathy

• Registration Number: DRKS00011029
• Lead Sponsor: K2M, Inc. a subsidiary of Stryker Corporation Stryker Spine”

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-07
• Study Completion: 2023-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 63

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified