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The chronOS Strip is a synthetic bone void filler manufactured from chronOS beta-tricalcium phosphate (β-TCP) granules and a resorbable polymer [poly(lactide co-ε-caprolactone)]. The chronOS Strip, combined with autogenous bone and/or bone marrow or autograft, is intended to be used in the spine for posterolateral fusion.
The purpose of this prospective, multi-center clinical case series was to evaluate posterolateral fusion rates in a prospective series of patients with degenerative disc disease. The surgical procedure consisted of instrumented posterolateral fusion with interbody support. The chronOS Strip, combined with bone marrow aspirate and local bone, was applied to the posterolateral gutters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chronOS Strip | Experimental | This is a single arm, outcome study for treatment of patients with degenerative disc disease (DDD), with or without stenosis, with interbody fusion, posterolateral pedicle screw system, and the study device (chronOS Strip). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chronOS Strip | Device | chronOS strip combined with bone marrow aspirate plus local bone |
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| Measure | Description | Time Frame |
|---|---|---|
| Posterolateral Fusion Success | The primary outcome for posterolateral fusion status was a composite endpoint incorporating posterior bridging bone status, intersegmental motion (angular and translational motion) and posterior hardware status. To have successful posterolateral fusion, a subject had to be successful in all four components at all levels under investigation. Failure to meet any one of the four components indicated failed posterolateral fusion status. | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function. |
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Inclusion Criteria:
Has the following indication for posterolateral fusion (transverse process and facet fusion) with posterior rod and screw fixation:
• Degenerative Disc Disease (DDD), with or without stenosis. Diagnosis of DDD requires back and/or leg (radicular) pain along with:
Has one or two motion segment(s) to be fused between L2 and S1;
Skeletally mature adult, at least 18 years of age at the time of surgery;
Oswestry Low Back Pain Disability Questionnaire score ≥ 30 (out of 100);
Has completed at least 6 months of conservative therapy, which may include physical therapy, bracing, systemic or injected medications;
Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures;
Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Hartford Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | chronOS Strip | Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Month 24 |
| Percent Change in Oswestry Disability Index (ODI) | The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function. Percent change in ODI score was calculated as: [(Month 24-Baseline)/Baseline]*100%. | Month 24 |
| Back Pain on Visual Analog Scale | The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. | Month 24 |
| Percent Change in Back Pain on Visual Analog Scale | The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%. | Month 24 |
| Leg Pain on Visual Analog Scale | The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. | Month 24 |
| Percent Change in Leg Pain on Visual Analog Scale | The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%. | Month 24 |
| Short Form 12 (SF-12v2) Physical Component Summary (PCS) | The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69). | Month 24 |
| Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS) | The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69). Percent change was calculated as [(Month 24 - Baseline)/Baseline]*100%. | Month 24 |
| Short Form 12 (SF-12v2) Mental Component Summary (MCS) | The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70). | Month 24 |
| Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS) | The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70). Percent change was calculated as [(Month 24 - Baseline)/Baseline]*100%. | Month 24 |
| Hartford |
| Connecticut |
| 06102 |
| United States |
| Bay Area Neurosurgery | Brandon | Florida | 33511 | United States |
| Atlanta Neurosurgical Associates | Decatur | Georgia | 30033 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| The Boston Spine Group | Newton | Massachusetts | 02458 | United States |
| Southern New York Neurosurgical Group | Johnson City | New York | 13790 | United States |
| The Rothman Institute | Philadelphia | Pennsylvania | 19020 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| UPMC Presbyterian Dept. of Neurosurgery | Pittsburgh | Pennsylvania | 15213 | United States |
| Vanderbilt University Medical Center Department of Neurosurgery/Spine Research | Nashville | Tennessee | 37232 | United States |
| Orthopaedic and Spine Center | Newport News | Virginia | 23606 | United States |
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| Treated on Protocol |
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| COMPLETED |
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| NOT COMPLETED |
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Number of subjects treated per protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | chronOS Strip | Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Level(s) treated | Subjects were treated at one or two contiguous levels from L2 through S1 | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Posterolateral Fusion Success | The primary outcome for posterolateral fusion status was a composite endpoint incorporating posterior bridging bone status, intersegmental motion (angular and translational motion) and posterior hardware status. To have successful posterolateral fusion, a subject had to be successful in all four components at all levels under investigation. Failure to meet any one of the four components indicated failed posterolateral fusion status. | The primary endpoint was evaluated for the per-protocol population. Of the 55 patients who were evaluated at the Month 24 visit, six patients were missing complete radiographic data needed to evaluate the primary endpoint. | Posted | Number | participants | Month 24 |
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| Secondary | Oswestry Disability Index (ODI) | The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function. | Per protocol | Posted | Mean | Standard Deviation | units on a scale | Month 24 |
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| Secondary | Percent Change in Oswestry Disability Index (ODI) | The Oswestry Low Back Pain Disability Questionnaire was self-administered to each subject preoperatively and at each clinical follow up examination. Each of the ten questions had six ordered responses coded on a scale from zero to five. The scale ranges from 0-100. A higher score indicates a higher level of disability, and a negative percent change (post surgery minus baseline) indicates improved function. Percent change in ODI score was calculated as: [(Month 24-Baseline)/Baseline]*100%. | Per protocol | Posted | Mean | Standard Deviation | percent change | Month 24 |
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| Secondary | Back Pain on Visual Analog Scale | The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. | Of the 55 subjects who were evaluated at Month 24, two were missing back pain data. | Posted | Mean | Standard Deviation | units on a scale | Month 24 |
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| Secondary | Percent Change in Back Pain on Visual Analog Scale | The subjects completed questionnaires assessing the intensity of pain experienced in the back at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%. | Back pain was assessed in the per-protocol population. Of the 55 subjects who were evaluated at the Month 24 visit, two were missing data related to back pain. | Posted | Mean | Standard Deviation | percent change | Month 24 |
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| Secondary | Leg Pain on Visual Analog Scale | The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. | Per protocol. | Posted | Mean | Standard Deviation | units on a scale | Month 24 |
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| Secondary | Percent Change in Leg Pain on Visual Analog Scale | The subjects completed questionnaires assessing the intensity of pain experienced in the leg at the preoperative visit and at all visits postoperatively. Pain intensity was rated on a scale where zero indicated no pain, and 100 represented the worst possible pain. A negative change (post surgery minus baseline) indicated an improvement. Percent change was calculated as: [(Month 24-Baseline)/Baseline]*100%. | Per protocol | Posted | Mean | Standard Deviation | percent change | Month 24 |
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| Secondary | Short Form 12 (SF-12v2) Physical Component Summary (PCS) | The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69). | Per protocol | Posted | Mean | Standard Deviation | units on a scale | Month 24 |
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| Secondary | Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS) | The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, PCS was scored by aggregating the eight scales using a standardized algorithm. Finally, PCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 13-69). Percent change was calculated as [(Month 24 - Baseline)/Baseline]*100%. | Per protocol | Posted | Mean | Standard Deviation | percent change | Month 24 |
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| Secondary | Short Form 12 (SF-12v2) Mental Component Summary (MCS) | The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70). | Per protocol | Posted | Mean | Standard Deviation | units on a scale | Month 24 |
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| Secondary | Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS) | The SF-12v2, comprising 12 questions related to health and wellbeing over the prior four weeks, was administered to subjects preoperatively and at all follow up visits. SF-12v2 represents overall subjective health status by measuring eight health-related parameters (each scored from 0 [poor health] to 100 [better health]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. First, the eight scales were standardized using means and standard deviations (SD) for the general US population. Second, MCS was scored by aggregating the eight scales using a standardized algorithm. Finally, MCS was standardized using a linear t-score transformation to have a mean of 50 and a SD of 10 in the general US population (expected range: 10-70). Percent change was calculated as [(Month 24 - Baseline)/Baseline]*100%. | Per protocol | Posted | Mean | Standard Deviation | percent change | Month 24 |
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Adverse events were collected through the Month 24 visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | chronOS Strip | Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone. | 24 | 81 | 34 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal laboratory value | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiovascular | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
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| Surgery, other | Surgical and medical procedures | Systematic Assessment |
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| Infection, non-wound related | Infections and infestations | Systematic Assessment |
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| Dural tear | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fever | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cervical whiplash | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cervical disc rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee meniscus tear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain: back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain: back and legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Surgery, index level | Surgical and medical procedures | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Neurological | Nervous system disorders | Systematic Assessment |
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| Stroke | Nervous system disorders | Systematic Assessment |
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| Psychological | Psychiatric disorders | Systematic Assessment |
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| Genitourinary | Renal and urinary disorders | Systematic Assessment |
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| Routine vaginal delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wound issues, other | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Thrombosis | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurological | Nervous system disorders | Systematic Assessment |
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| Pain, back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain, back and legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain, legs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain, other | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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Limitations included lack of control arm, no hypothesis for primary endpoint, & qualitative sample size estimate. chronOS Strip was used according to its FDA-cleared labeling; other usage was outside the study scope and was not evaluated clinically.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allyson Morris, PhD, CCRP, Staff Clinical Research Scientist | DePuy Synthes Clinical Affairs | 610-719-5298 | morris.allyson@synthes.com |
| One level, L4-5 |
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| One-level, L5-S1 |
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| Two-level, L3-5 |
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| Two-level, L4-S1 |
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