Degeneration of Lumbar Intervertebral DiscNCT00943384
Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate
A study testing chronOS Strip in people with Degeneration of Lumbar Intervertebral Disc, run by Synthes USA HQ, Inc. at 13 sites in United States.
Trial summary
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)]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degeneration of Lumbar Intervertebral Disc
- What is being tested?
- chronOS Strip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2009to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Instability (≥ 3 mm translation or ≥ 5° angulation); or
- MRI confirmation of Modic Type 1 or Type 2 changes; or
- High intensity zones in the disc space.
- Has one or two motion segment(s) to be fused between L2 and S1;
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- 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.
Who cannot join
- Three or more motion segments to be fused;
- Degenerative scoliosis, defined as Cobb angle > 10° at any level in lumbar spine;
- Has had a previous interbody fusion or posterolateral fusion attempt at any level of the lumbar spine;
- Active systemic or local infection;
- Known or documented history of communicable disease, including AIDS and HIV;
- Active Hepatitis (receiving medical treatment within two years);
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- Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
- Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
- Known history of Paget's disease, osteomalacia, or any other metabolic bone disease;
- Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a dual energy x-ray absorptiometry (DXA) bone mineral density measurement. If DXA is required, exclusion will be defined as a DXA bone density measured T score less than or equal to -1.0.
- Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight;
- Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
- Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
- Pregnant or planning to become pregnant during study period;
- Involved in study of another investigational product that may affect outcome;
- History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales;
- Patients who are incarcerated.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Bay Area Neurosurgery
Brandon, Florida, 33511
Northwestern University
Chicago, Illinois, 60611
Atlanta Neurosurgical Associates
Decatur, Georgia, 30033
Hartford Hospital
Hartford, Connecticut, 06102
Southern New York Neurosurgical Group
Johnson City, New York, 13790
University of Kansas Medical Center
Kansas City, Kansas, 66160
Vanderbilt University Medical Center Department of Neurosurgery/Spine Research
Nashville, Tennessee, 37232
Orthopaedic and Spine Center
Newport News, Virginia, 23606
The Boston Spine Group
Newton, Massachusetts, 02458
The Rothman Institute
Philadelphia, Pennsylvania, 19020
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
UPMC Presbyterian Dept. of Neurosurgery
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate Plus Local Bone for Posterolateral Lumbar Interbody Fusion or Lumbosacral Interbody Fusion
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.
- Being tested
- chronOS Strip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronOS StripDevice
Also called beta-tricalcium phosphate
chronOS strip combined with bone marrow aspirate plus local bone
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: chronOS Strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 24
Secondary outcomes (10)
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.
Measured: 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%.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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%.
Measured: 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).
Measured: 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%.
Measured: 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).
Measured: 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%.
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degeneration of Lumbar Intervertebral DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes USA HQ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943384
- Sponsor's protocol ID
- chronOS-050709
- Status last verified
- Nov 2014
- First submitted
- 21 Jul 2009
- Last updated
- 26 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate Plus Local Bone for Posterolateral Lumbar Interbody Fusion or Lumbosacral Interbody Fusion
- ClinicalTrials.gov ID
- NCT00943384
- Acronym / sponsor ID
- chronOS-050709
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Synthes USA HQ, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Posted 26 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronOS Strip | Experimental | Device: chronOS StripThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Has the following indication for posterolateral fusion (transverse process and facet fusion) with posterior rod and screw fixation:
- 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;
Key exclusion criteria (17 listed)
- Three or more motion segments to be fused;
- Degenerative scoliosis, defined as Cobb angle > 10° at any level in lumbar spine;
- Has had a previous interbody fusion or posterolateral fusion attempt at any level of the lumbar spine;
- Active systemic or local infection;
- Known or documented history of communicable disease, including AIDS and HIV;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chronOS StripAlso: beta-tricalcium phosphatechronOS strip combined with bone marrow aspirate plus local bone | Device | chronOS Strip |
Primary outcome
Posterolateral Fusion Success
Time frame: Month 24
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.
10 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Month 24
Percent Change in Oswestry Disability Index (ODI)
Time frame: Month 24
Back Pain on Visual Analog Scale
Time frame: Month 24
Percent Change in Back Pain on Visual Analog Scale
Time frame: Month 24
Leg Pain on Visual Analog Scale
Time frame: Month 24
Percent Change in Leg Pain on Visual Analog Scale
Time frame: Month 24
Short Form 12 (SF-12v2) Physical Component Summary (PCS)
Time frame: Month 24
Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS)
Time frame: Month 24
Short Form 12 (SF-12v2) Mental Component Summary (MCS)
Time frame: Month 24
Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS)
Time frame: Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chronOS Strip in people with Degeneration of Lumbar Intervertebral Disc, run by Synthes USA HQ, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posterolateral Fusion Success (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.