Safety and Efficacy of the CarboClear Pedicle Screw System

NCT02626624 | Completed Results DMC FDA Device

• 1 other identifier: CARBOCLEAR P_CLD 2492_US
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 8

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.

Conditions

Degenerative Disc Disease; Spondylolisthesis, Grade 1

Outcome Measures

Primary Outcomes (4)

• Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.

  Fusion was assessed at follow-up visits, starting at 6 months post operation. Fusion is defined as: 1. Angular motion ˂ 3º; AND 2. Translational motion ˂ 3 mm; AND 3. Presence of continuous bridging bone between the involved motion segment, i.e.: * Presence of interbody (between endplates) bridging bone and absence of radiolucency \> 50%; OR * Presence of right posterolateral bridging bone; OR * Presence of left posterolateral bridging bone.

  24 months

• Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire

  Pain was assessed using the Visual Analogue Scale (VAS) preoperatively and at follow-up visits. The scale ranges from 0 mm ("No Pain") to 100 mm ("Severe Pain"). Patients were instructed to draw a single line across the scale at the point that best described their level of pain. Pain improvement was evaluated at each location (i.e., low back, right leg, and left leg) and was defined as a reduction of at least 20 mm on a 100 mm VAS from baseline level at 24 months. Eligible patients experienced preoperative low back and/or leg pain (debilitating pain that significantly disrupted daily physical activities) with a VAS score of ≥40 mm.

  24 months

• Function: Assessed by Oswestry Disability Index (ODI) Patient Questionnaire

  The Oswestry Disability Index (ODI) is a patient-reported questionnaire administered preoperatively and at follow-up visits. The ODI consists of ten questions focusing on pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Each question has six possible responses. The response scale ranges from 0 to 5 points, with a lower score indicating better function and lower pain (0 points for full functionality with no or minimal pain; 5 points for inability to perform the function due to pain). The total ODI score is calculated by summing the individual question scores and dividing the total by the maximum possible score (50 if all questions are answered), yielding a percentage. ODI scores range from 0% to 100%, with lower percentages indicating reduced pain and disability. The functional outcome measure was defined as an improvement of at least 15 points from baseline at 24 months.

  24 months

• Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level.

  1. Worsening in neurological status (motor, sensory, reflex, straight leg raising, and tenderness assessments) and no new permanent neurological deficits present for at least 2 successive visits at or beyond 6 months (out to 24 months); 2. Device-related serious adverse events (SAEs) through 24 months; 3. Subsequent surgical interventions at the index level through 24 months.

  Throughout the study until 24 months

Secondary Outcomes (4)

• Subject's Overall Well-Being: Assessed by 12-Item Short Form Health Survey (SF-12) Patient Questionnaire

  24 months

• Patient Satisfaction: Assessed Based on VAS Patient Questionnaire.

  24 months

• Operation Time [Min]

  During operation (skin-to-skin)

• Blood Loss During Operation [ml]

  During operation (skin to skin)

Study Arms (1)

single arm

EXPERIMENTAL

CarboClear Pedicle Screw System

Device: Implantation of the CarboClear Pedicle Screw System

Interventions

Implantation of the CarboClear Pedicle Screw System DEVICE

single arm

Eligibility Criteria

• Age: 21 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject is candidate for single level intervertebral fusion, with or without posterolateral fusion, with implantation of intervertebral body fusion device and supplemental fixation.
• Subject age is between 21 - 72 years, and subject is skeletally mature.
• 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).
• Pre-operative Oswestry Disability Index (ODI) score ≥ 40 percentage-point, indicating at least moderate disability (interpreted as moderate/severe disability).
• 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.
• Patient must understand and sign the informed consent.
• Patient is willing and able to meet the proposed follow-up schedule including return to follow-up visits and complete necessary study paperwork.

You may not qualify if:

• Previous fusion or fusion attempts, including anterior fusion or posterolateral fusion, at the index level.
• Previous fusion or fusion attempts at the adjacent levels.
• Prior decompression procedures that include removal of soft and bone tissue at the index or adjacent levels.
• Patient is not skeletally mature.
• Degenerative spondylolisthesis greater than Grade I.
• 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.
• Isthmic spondylolisthesis.
• 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.
• Systemic infection or infection at the site of surgery.
• 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.
• Personal and/or familial history NF2, and/or spinal tumor.
• Ankylosing spondylitis.
• Diffuse idiopathic skeletal hyperostosis (DISH) syndrome.
• 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.
• Immune deficiency disease.

Sponsors & Collaborators

• CarboFix Orthopedics Ltd.: lead
• CarboFix Orthopedics Inc.: collaborator

Study Sites (8)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Brooklyn Hospital

Brooklyn, New York, 11201, United States

Location

Crystal Clinic Orthopaedic Center

Akron, Ohio, 44333, United States

Location

St. David's Round Rock Medical Center

Austin, Texas, 78705, United States

Location

Herzliya Medical Center

Herzliya, 4685107, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Assuta Medical Center - Israel Spine Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

This IDE study encountered a challenging follow-up schedule due to the COVID-19 pandemic. In particular, for several subjects, the 24-month visit occurred during the pandemic period, and was the cause for not attending this visit. On top of quarantine and limitations posed by authorities, a few subjects refused to arrive to hospital during that period.

Results Point of Contact

• Title: Dvir Sherpsky, Director of Clinical Trials
• Organization: CarboFix Orthopedics Ltd.

dvir@carbo-fix.com

+972-54-770-9920

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 10, 2015
• Study Start: December 27, 2015
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); IL (3)