Clinical trial NCT02626624: Safety and Efficacy of the CarboClear Pedicle Screw System
Official title: CarboClear Pedicle Screw System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Disc Disease
Spondylolisthesis, Grade 1
Lead sponsor: CarboFix Orthopedics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: CarboFix Orthopedics Inc.
First posted: 2015-12-10
Enrollment: 57
Sex: ALL
Minimum age (years): 21
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device, and requiring immediate, rigid, posterior spinal stabilization of the lumbar and/or sacral spine.

Detailed description: A prospective, multi-center, confirmatory, single arm, study. Results of the study will be compared to data from the literature.

The CarboClear Pedicle Screw System is designed for use with intervertebral body fusion device and with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, using PLIF or TLIF.

A total of 55 subjects will participate in the study, with up to 25 patients recruited at sites in Israel and at least 30 patients will be enrolled in US sites.

Follow-ups: Radiographic (AP, lateral and flexion/extension X-Rays) and clinical evaluations.

Follow-up sessions at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively, and then annually, until the last patient has completed 2-year follow-up.

Eligibility criteria: Inclusion Criteria:

1. Subject has degenerative disc disease (DDD) at one level, from L2 to S1 vertebrae, with up to Grade I spondylolisthesis.

   DDD is defined as back pain and/or radicular leg pain with degeneration of the disc confirmed by patient history, radiographic studies, and physical examination, with one or more of the following factors (as measured radiographically, either by CT, MRI or plain film, myelography, discography, etc.):
   * osteophyte formation of facet joints or vertebral endplates;
   * decreased disc height, on average by \> 2 mm;
   * scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule;
   * herniated nucleus pulposus;
   * facet joint degeneration/changes;
   * vacuum phenomenon.
2. Subject is candidate for single level intervertebral fusion, with or without posterolateral fusion, with implantation of intervertebral body fusion device and supplemental fixation.
3. Subject age is between 21 - 72 years, and subject is skeletally mature.
4. Pre-operative low back and/or leg/s pain (debilitating pain that causes a significant disturbance of the routine daily physical activities) ≥ 40 mm on a 100 mm Visual Analogue Scale (VAS).
5. Pre-operative Oswestry Disability Index (ODI) score ≥ 40 percentage-point, indicating at least moderate disability (interpreted as moderate/severe disability).
6. Low back and/or leg/s pain is unresponsive to prior non-surgical management for a minimum of six months. Non-operative treatment includes pain medication, physical therapy and/or injections.
7. Patient must understand and sign the informed consent.
8. Patient is willing and able to meet the proposed follow-up schedule including return to follow-up visits and complete necessary study paperwork.
9. Patient is willing and able to follow the postoperative management program.

Exclusion Criteria:

1. Previous fusion or fusion attempts, including anterior fusion or posterolateral fusion, at the index level.
2. Previous fusion or fusion attempts at the adjacent levels.
3. Prior decompression procedures that include removal of soft and bone tissue at the index or adjacent levels.
4. Patient is not skeletally mature.
5. Degenerative spondylolisthesis greater than Grade I.
6. Spinal instability at the index level with ≥ 3 mm translation and/or ≥ 5 degrees angulation. Determination of instability will be assessed using flexion/extension lateral view radiographs.
7. Isthmic spondylolisthesis.
8. Radiographically confirmed moderate or severe spinal stenosis with associated neurogenic claudication. Radiographically confirmed moderate/severe stenosis is defined as reduction of ˃50% of central and/or foraminal canal diameter compared to the adjacent uninvolved levels. Neurogenic claudication is leg, groin or buttock pain and/or numbness that worsens with walking or erect posture and is relieved with flexion of the spine.
9. Systemic infection or infection at the site of surgery.
10. Metabolic bone disease, such as osteopenia, osteoporosis, and osteomalacia. A screening Questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required, exclusion will be defined as measured T-score less than or equal to -2.5 (WHO definition).
11. History of Paget's disease or other bone pathologies, whether acquired or congenital, including renal osteodystrophy, untreated or uncontrolled hyperthyrodism, hypothyroidism, hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
12. Personal and/or familial history NF2, and/or spinal tumor.
13. Ankylosing spondylitis.
14. Diffuse idiopathic skeletal hyperostosis (DISH) syndrome.
15. Active hepatitis (viral or serum) or HIV positive, renal failure, systemic lupus erythematosus, or any other significant medical conditions which would substantially increase the risk of surgery.
16. Immune deficiency disease.
17. Patient is receiving immunosuppressive or long-term steroid therapy.
18. Active malignancy or other significant medical comorbidities.
19. All concomitant diseases that can jeopardize the functioning and success of the patient.
20. Allergy to any component of the investigational device, including carbon fiber-reinforced polyetheretherketone (CFR-PEEK), titanium, and tantalum.
21. Pregnancy, or female subject interested in become pregnant during the duration of the study.
22. Current chemical dependency (e.g., drug and/or alcohol abuse, according to DSM-V definition), as well as those with a history of such abuse.
23. Uncontrolled depression, psychosis, or other symptoms of a mental disorder that, in the investigator's opinion, likely would make the subject unable to comply with the study procedures and could affect the study outcome.
24. Treatment with drugs that may interfere with bone metabolism, such as glucocorticosteroids, calcitonin, bisphosphonates, bone therapeutic doses of fluoride, bone therapeutic doses of vitamin D or vitamin D metabolites, and treatment by chemotherapy.
25. Morbid obesity (BMI ≥ 40).
26. Current smokers (including 3 months prior to surgery).
27. Scoliosis, Cobb angle greater than 11°.
28. Vertebral fractures.
29. Severe muscular, neural or vascular diseases that endanger the spinal column.
30. Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible.
31. Paralysis.
32. Current use of other investigational drug or device.
33. The patient is involved in a worker's compensation case or spine-related litigation.
34. The patient is a prisoner.

Primary outcomes:
measure: Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.
timeFrame: 24 months
measure: Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire
timeFrame: 24 months
measure: Function: Assessed by Oswestry Disability Index (ODI) Patient Questionnaire
timeFrame: 24 months
measure: Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level.
timeFrame: Throughout the study until 24 months
Secondary outcomes:
measure: Subject's Overall Well-Being: Assessed by 12-Item Short Form Health Survey (SF-12) Patient Questionnaire
timeFrame: 24 months
measure: Patient Satisfaction: Assessed Based on VAS Patient Questionnaire.
timeFrame: 24 months
measure: Operation Time [Min]
timeFrame: During operation (skin-to-skin)
measure: Blood Loss During Operation [ml]
timeFrame: During operation (skin to skin)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Brooklyn
country: United States
facility: The Brooklyn Hospital
state: New York
city: Akron
country: United States
facility: Crystal Clinic Orthopaedic Center
state: Ohio
city: Austin
country: United States
facility: St. David's Round Rock Medical Center
state: Texas
city: Herzliya
country: Israel
facility: Herzliya Medical Center
city: Kefar Saba
country: Israel
facility: Meir Medical Center
city: Tel-Aviv
country: Israel
facility: Assuta Medical Center - Israel Spine Center
Study officials:
References: