Trial Outcomes & Findings for Safety and Efficacy of the CarboClear Pedicle Screw System (NCT NCT02626624)

Last Updated: 2025-04-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

24 months

Results posted on

2025-04-27

Participant Flow

The single arm study was approved for a total of 55 subjects, and was conducted at 5 US sites and 3 Israeli sites.

A one arm study (no assignment to groups)

Participant milestones

Participant milestones
Measure	CarboClear Pedicle Screw System (Single Arm Study) Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion.
Overall Study STARTED	57
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	CarboClear Pedicle Screw System (Single Arm Study) Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	3
Overall Study Protocol Violation	4
Overall Study Death	2

Baseline Characteristics

Mean VAS is calculated for subjects with preoperative VAS pain ≥ 40 mm on a 100 mm VAS (which is regarded as debilitating pain that causes a significant disturbance of the routine daily physical activities).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=57 Participants Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Age, Customized Age	55.16 years STANDARD_DEVIATION 12.90 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	55 Participants n=5 Participants
Race/Ethnicity, Customized African	2 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants
Region of Enrollment Israel	26 participants n=5 Participants
Indications DDD + Spondylolisthesis up to Grade I + Mild Stenosis (< 50%)	53 Participants n=5 Participants
Indications DDD + Spondylolisthesis up to Grade I	1 Participants n=5 Participants
Indications DDD + Mild Stenosis (< 50%)	2 Participants n=5 Participants
Indications DDD	1 Participants n=5 Participants
Pain using Visual Analogue Scale (VAS) Lower Back Pain (VAS)	81.83 units on a scale STANDARD_DEVIATION 17.60 • n=5 Participants • Mean VAS is calculated for subjects with preoperative VAS pain ≥ 40 mm on a 100 mm VAS (which is regarded as debilitating pain that causes a significant disturbance of the routine daily physical activities).
Pain using Visual Analogue Scale (VAS) Right Leg Pain (VAS)	61.80 units on a scale STANDARD_DEVIATION 34.97 • n=5 Participants • Mean VAS is calculated for subjects with preoperative VAS pain ≥ 40 mm on a 100 mm VAS (which is regarded as debilitating pain that causes a significant disturbance of the routine daily physical activities).
Pain using Visual Analogue Scale (VAS) Left Leg Pain (VAS)	56.32 units on a scale STANDARD_DEVIATION 37.45 • n=5 Participants • Mean VAS is calculated for subjects with preoperative VAS pain ≥ 40 mm on a 100 mm VAS (which is regarded as debilitating pain that causes a significant disturbance of the routine daily physical activities).
Function using Oswestry Disability Index (ODI)	57.71 units on a scale STANDARD_DEVIATION 12.14 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: 24-month radiographic data is available for 49 patients (for patients that attended the 24-month visit, or for non-attendees for whom data is available from earlier visits (e.g., where fusion was confirmed).

Outcome measures

Outcome measures
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=49 Participants Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Fusion: Evaluated Radiographically (by AP, Lateral and Flexion/Extension X-Rays) by Independent Radiographic Core Lab.	42 Participants

PRIMARY outcome

Timeframe: 24 months

Population: VAS pain data is available at 24 months for 45 patients who attended 24-month visit and for whom VAS assessment is available. Analysis is presented for patients with preoperative pain VAS score ≥40 (in accordance with the clinical investigational plan).

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.

Outcome measures

Outcome measures
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=45 Participants Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire Pain Improvement (VAS) - Low Back	58.52 score on a scale Standard Deviation 31.89
Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire Pain Improvement (VAS) - Right Leg	58.11 score on a scale Standard Deviation 35.46
Pain (Low Back and/or Leg/s): Assessed Based on Visual Analogue Scale (VAS) Patient Questionnaire Pain Improvement (VAS) - Left Leg	59.06 score on a scale Standard Deviation 32.99

PRIMARY outcome

Timeframe: 24 months

Population: Function (ODI) data is available at 24 months for 45 patients who attended 24-month visit and for whom function assessment is available.

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.

Outcome measures

Outcome measures
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=45 Participants Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Function: Assessed by Oswestry Disability Index (ODI) Patient Questionnaire	34.39 score on a scale Standard Deviation 21.43

PRIMARY outcome

Timeframe: Throughout the study until 24 months

Population: All subjects that completed the study the study

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.

Outcome measures

Outcome measures
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=55 Participants Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level. Neurological deterioration	3 Participants
Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level. Device related serious adverse events	0 Participants
Safety: Neurological Deterioration, Device Related Serious Adverse Events, Additional Surgical Intervention at Index Level. Subsequent surgical interventions at the index level	4 Participants

SECONDARY outcome

Timeframe: 24 months

Population: Out of the patients attended the 24-month visit, 43 patients had SF-12 assessment.

Subject's overall well-being (quality of life) was assessed preoperatively and at follow-up visits, using the 12-Item Short Form Health Survey (SF-12), which is a multipurpose short-form quality of life instrument with 12 questions selected from the SF-36 Health Survey. SF-12 questionnaire is designed to measure general health status from the patient's point of view. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health Scales within the SF-12 instrument. The MCS is a composite of the Vitality, Social Functioning, Role-Emotional and Mental Health Scales within the SF-12 instrument. The SF-12 is a normative based instrument. PCS and MCS are computed using the rating on 12 questions from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level.

Outcome measures

Outcome measures
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=43 Participants Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Subject's Overall Well-Being: Assessed by 12-Item Short Form Health Survey (SF-12) Patient Questionnaire SF-12 PCS Change	14.50 score on a scale Standard Deviation 14.45
Subject's Overall Well-Being: Assessed by 12-Item Short Form Health Survey (SF-12) Patient Questionnaire SF-12 MCS Change	10.45 score on a scale Standard Deviation 13.90

SECONDARY outcome

Timeframe: 24 months

Satisfaction was assessed at postoperative follow-up visits including at 24-month visit, using a 100 mm VAS (the anchor points are "Completely Not Satisfied" (0 mm) and "Completely Satisfied" (100 mm)). 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.

Outcome measures

Outcome measures
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=45 Participants Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Patient Satisfaction: Assessed Based on VAS Patient Questionnaire.	81.19 score on a scale Standard Deviation 32.20

SECONDARY outcome

Timeframe: During operation (skin-to-skin)

Population: All 55 patients that participated in the study

Operation time (skin-to-skin) was recorded for each subject.

Outcome measures

Outcome measures
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=55 Participants Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Operation Time [Min]	135.20 minutes Standard Deviation 73.38

SECONDARY outcome

Timeframe: During operation (skin to skin)

Population: All 55 patients that participated in the study

The volume of blood loss during operation was recorded for each subject.

Outcome measures

Outcome measures
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=55 Participants Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Blood Loss During Operation [ml]	212.64 milliliter Standard Deviation 127.90

Adverse Events

CarboClear Pedicle Screw System (Single Arm Study)

Serious events: 7 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	CarboClear Pedicle Screw System (Single Arm Study) n=57 participants at risk Patients with Degenerative Disc Disease (DDD) at one level (L2-S1), aged 21-71 years, who have failed to improve with conservative treatment with at least 6 months prior to enrolment. Implantation of the CarboClear Pedicle Screw System and interbody spinal fusion using an FDA cleared PEEK interbody fusion device (PLIF or TLIF approach); and posterolateral spinal fusion at the physician's discretion
Surgical and medical procedures Additional Surgery at index level	7.0% 4/57 • Number of events 4 • Evaluation of complications/adverse events was conducted at each follow-up session, as well as throughout the study (within 24 months). All adverse events (AEs), including non-serious AEs, non-device related, and anticipated AEs, were assessed by an independent Clinical Events Committee (CEC). AEs and serious adverse events (SAEs) were defined in accordance with the definition of ISO 14155.
Surgical and medical procedures Additional surgery at non-index level	3.5% 2/57 • Number of events 2 • Evaluation of complications/adverse events was conducted at each follow-up session, as well as throughout the study (within 24 months). All adverse events (AEs), including non-serious AEs, non-device related, and anticipated AEs, were assessed by an independent Clinical Events Committee (CEC). AEs and serious adverse events (SAEs) were defined in accordance with the definition of ISO 14155.
Vascular disorders Deep vein thrombosis	1.8% 1/57 • Number of events 1 • Evaluation of complications/adverse events was conducted at each follow-up session, as well as throughout the study (within 24 months). All adverse events (AEs), including non-serious AEs, non-device related, and anticipated AEs, were assessed by an independent Clinical Events Committee (CEC). AEs and serious adverse events (SAEs) were defined in accordance with the definition of ISO 14155.

Other adverse events

Adverse event data not reported

Additional Information

Dvir Sherpsky, Director of Clinical Trials

CarboFix Orthopedics Ltd.

Phone: +972-54-770-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place