Trial Outcomes & Findings for Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate (NCT NCT00943384)
NCT ID: NCT00943384
Last Updated: 2014-11-26
Results Overview
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.
COMPLETED
NA
104 participants
Month 24
2014-11-26
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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104
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Overall Study
Treated
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81
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Overall Study
Treated on Protocol
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76
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Overall Study
COMPLETED
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55
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Overall Study
NOT COMPLETED
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49
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Dispositioned prior to treatment
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23
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Overall Study
Treated off protocol-protocol violation
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5
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Overall Study
Lost to Follow-up
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16
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Overall Study
Withdrawal by Subject
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5
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Baseline Characteristics
Prospective, Multi-Center Clinical Outcomes Study Evaluating the chronOS Strip Combined With Bone Marrow Aspirate
Baseline characteristics by cohort
| Measure |
chronOS Strip
n=76 Participants
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.
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|---|---|
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Age, Continuous
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50.1 years
STANDARD_DEVIATION 10.37 • n=5 Participants
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Sex: Female, Male
Female
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40 Participants
n=5 Participants
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Sex: Female, Male
Male
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36 Participants
n=5 Participants
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Level(s) treated
One-level, L2-3
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1 participants
n=5 Participants
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Level(s) treated
One-level, L3-4
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1 participants
n=5 Participants
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Level(s) treated
One level, L4-5
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22 participants
n=5 Participants
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Level(s) treated
One-level, L5-S1
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18 participants
n=5 Participants
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Level(s) treated
Two-level, L3-5
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8 participants
n=5 Participants
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Level(s) treated
Two-level, L4-S1
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26 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Month 24Population: 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.
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.
Outcome measures
| Measure |
chronOS Strip
n=49 Participants
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.
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|---|---|
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Posterolateral Fusion Success
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45 participants
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SECONDARY outcome
Timeframe: Month 24Population: Per protocol
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.
Outcome measures
| Measure |
chronOS Strip
n=55 Participants
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.
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|---|---|
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Oswestry Disability Index (ODI)
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20.3 units on a scale
Standard Deviation 17.5
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SECONDARY outcome
Timeframe: Month 24Population: Per protocol
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%.
Outcome measures
| Measure |
chronOS Strip
n=55 Participants
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.
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|---|---|
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Percent Change in Oswestry Disability Index (ODI)
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-61.6 percent change
Standard Deviation 28.7
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SECONDARY outcome
Timeframe: Month 24Population: Of the 55 subjects who were evaluated at Month 24, two were missing back pain data.
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.
Outcome measures
| Measure |
chronOS Strip
n=53 Participants
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.
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|---|---|
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Back Pain on Visual Analog Scale
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29.5 units on a scale
Standard Deviation 27.3
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SECONDARY outcome
Timeframe: Month 24Population: 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.
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%.
Outcome measures
| Measure |
chronOS Strip
n=53 Participants
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.
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|---|---|
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Percent Change in Back Pain on Visual Analog Scale
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-56.6 percent change
Standard Deviation 52.8
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SECONDARY outcome
Timeframe: Month 24Population: Per protocol.
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.
Outcome measures
| Measure |
chronOS Strip
n=55 Participants
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.
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|---|---|
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Leg Pain on Visual Analog Scale
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21.1 units on a scale
Standard Deviation 28.1
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SECONDARY outcome
Timeframe: Month 24Population: Per protocol
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%.
Outcome measures
| Measure |
chronOS Strip
n=55 Participants
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.
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|---|---|
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Percent Change in Leg Pain on Visual Analog Scale
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-56.4 percent change
Standard Deviation 92.5
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SECONDARY outcome
Timeframe: Month 24Population: Per protocol
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).
Outcome measures
| Measure |
chronOS Strip
n=55 Participants
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.
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|---|---|
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Short Form 12 (SF-12v2) Physical Component Summary (PCS)
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39.2 units on a scale
Standard Deviation 8.0
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SECONDARY outcome
Timeframe: Month 24Population: Per protocol
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%.
Outcome measures
| Measure |
chronOS Strip
n=55 Participants
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.
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|---|---|
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Percent Change in Short Form 12 (SF-12v2) Physical Component Summary (PCS)
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17.7 percent change
Standard Deviation 31.4
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SECONDARY outcome
Timeframe: Month 24Population: Per protocol
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).
Outcome measures
| Measure |
chronOS Strip
n=55 Participants
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.
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|---|---|
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Short Form 12 (SF-12v2) Mental Component Summary (MCS)
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51.3 units on a scale
Standard Deviation 7.9
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SECONDARY outcome
Timeframe: Month 24Population: Per protocol
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%.
Outcome measures
| Measure |
chronOS Strip
n=55 Participants
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.
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|---|---|
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Percent Change in Short Form 12 (SF-12v2) Mental Component Summary (MCS)
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24.1 percent change
Standard Deviation 29.0
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Adverse Events
chronOS Strip
Serious adverse events
| Measure |
chronOS Strip
n=81 participants at risk
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.
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|---|---|
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Blood and lymphatic system disorders
Abnormal laboratory value
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
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Cardiac disorders
Cardiovascular
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7.4%
6/81 • Adverse events were collected through the Month 24 visit.
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Gastrointestinal disorders
Gastrointestinal
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
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Surgical and medical procedures
Surgery, other
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6.2%
5/81 • Adverse events were collected through the Month 24 visit.
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Infections and infestations
Infection, non-wound related
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
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Injury, poisoning and procedural complications
Dural tear
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2.5%
2/81 • Adverse events were collected through the Month 24 visit.
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Injury, poisoning and procedural complications
Fever
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
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Musculoskeletal and connective tissue disorders
Cervical whiplash
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
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Musculoskeletal and connective tissue disorders
Cervical disc rupture
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
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Musculoskeletal and connective tissue disorders
Gout
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
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Musculoskeletal and connective tissue disorders
Knee meniscus tear
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
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Musculoskeletal and connective tissue disorders
Pain: back
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2.5%
2/81 • Adverse events were collected through the Month 24 visit.
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Musculoskeletal and connective tissue disorders
Pain: back and legs
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2.5%
2/81 • Adverse events were collected through the Month 24 visit.
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Surgical and medical procedures
Surgery, index level
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3.7%
3/81 • Adverse events were collected through the Month 24 visit.
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Nervous system disorders
Headache
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
|
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Nervous system disorders
Neurological
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
|
|
Nervous system disorders
Stroke
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2.5%
2/81 • Adverse events were collected through the Month 24 visit.
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Psychiatric disorders
Psychological
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
|
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Renal and urinary disorders
Genitourinary
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
|
|
Pregnancy, puerperium and perinatal conditions
Routine vaginal delivery
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
|
|
Skin and subcutaneous tissue disorders
Wound issues, other
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
|
|
Vascular disorders
Thrombosis
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1.2%
1/81 • Adverse events were collected through the Month 24 visit.
|
Other adverse events
| Measure |
chronOS Strip
n=81 participants at risk
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.
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|---|---|
|
Nervous system disorders
Neurological
|
7.4%
6/81 • Adverse events were collected through the Month 24 visit.
|
|
Musculoskeletal and connective tissue disorders
Pain, back
|
12.3%
10/81 • Adverse events were collected through the Month 24 visit.
|
|
Musculoskeletal and connective tissue disorders
Pain, back and legs
|
13.6%
11/81 • Adverse events were collected through the Month 24 visit.
|
|
Musculoskeletal and connective tissue disorders
Pain, legs
|
7.4%
6/81 • Adverse events were collected through the Month 24 visit.
|
|
Musculoskeletal and connective tissue disorders
Pain, other
|
11.1%
9/81 • Adverse events were collected through the Month 24 visit.
|
Additional Information
Allyson Morris, PhD, CCRP, Staff Clinical Research Scientist
DePuy Synthes Clinical Affairs
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60