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The purpose of this study is to compare the healing of the patients spine at 24-months following surgery and screw placement among 3 groups. The doctor will also compare clinical outcomes and the immediate and delayed medical and surgical complications among the 3 study groups. The goal of this study is to determine if treating patients with one of the 3 groups is better than the others.
Patient must be between 18 and 80 years old and have problems with the bones in there lower back (lumbar disease) for which Cautious management over at least 3 months has not brought relief from back and/or leg pain. Patients will be scheduled to undergo surgery to treat there lumbar disease. The surgery will be followed by placement of screws in the back of the bones of there lower back. This includes placing solid metal rods that are connected and secured to adjacent vertebrae (bones of the back) using screws. The screws are used to hold the spine together. Everyone who takes part in this study will be assigned to one of the following 3 study groups: 1) One-sided screw placement into the bones above and below the area where the nerve is being surgically relieved of its pinching; 2) Same as group 1 but with an additional stand alone screw which crosses the spinal joint placed into the joint on the other side; 3) Screw placement on both sides into the bones above and below the area where the nerve is being surgically relieved of its pinching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Unilateral pedicle screws |
|
| Group 2 | Other | Ipsilateral pedicle screws, contralateral facet screw |
|
| Group 3 | Other | Bilateral pedicle screws |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedicle Screw | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare Bony Fusion Rates Radiographically Using CT Scans | Primary Outcome: To compare bony fusion rates at two years among the three study arms, using the Brantigan, Steffee and Fraser scale. Post-operative CT scans will be evaluated at 24 months for evidence of new solid osseous trabeculations bridging across the interspace. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bony Fusion Rates Compared Clinically Using the Visual Analog Scale (VAS) Survey | To compare clinical outcomes among the three study arms utilizing the Visual Analog Scale (VAS) survey. Visual analog scales will be used to assess neck, back, arm, and leg pain. Scores can range from 0 - 10 with higher scores indicating higher levels of pain. | 3 months, 6 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome: Immediate and Delayed Medical and Surgical Complications Compared Among the Three Arms | Immediate and delayed medical and surgical (including neurological) complications among the three study arms will be compared. | post-surgery, 6 weeks, 3 months, 6 months, 12 months, 24 months |
| Exploratory Outcome: Compare Bony Fusion Rates Using X-ray Based Classification Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. Francis Farhadi, MD, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State Unviersity | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Unilateral | Unilateral pedicle screws Pedicle Screw |
| FG001 | Group 2: Ipsilateral | Ipsilateral pedicle screws, contralateral facet screw Pedicle Screw |
| FG002 | Group 3: Bilateral | Bilateral pedicle screws Pedicle Screw |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subject ethnicity: White
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Unilateral pedicle screws Pedicle Screw |
| BG001 | Group 2 | Ipsilateral pedicle screws, contralateral facet screw Pedicle Screw |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Compare Bony Fusion Rates Radiographically Using CT Scans | Primary Outcome: To compare bony fusion rates at two years among the three study arms, using the Brantigan, Steffee and Fraser scale. Post-operative CT scans will be evaluated at 24 months for evidence of new solid osseous trabeculations bridging across the interspace. | Research has been discontinued. Data not collected and therefore not analyzed. | Posted | 24 months |
|
Enrollment to 24 Months post surgery
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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 | Group 1 | Unilateral pedicle screws Pedicle Screw | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Compression Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Required surgical repair |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Chronic Back and/or Leg Pain | Nervous system disorders | Systematic Assessment | When appropriate treated with Valium and/or ESIs or no treatment |
This study is being ended early due to low enrollment. No analysis is planned due to the small cohort.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelby Miracle | OhioU | 614-366-1648 | shelby.miracle@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2016 | Apr 22, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2017 | Apr 19, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065289 | Pedicle Screws |
| ID | Term |
|---|---|
| D001863 | Bone Screws |
| D016268 | Internal Fixators |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| Bony Fusion Rates Compared Clinically Using the Oswestry Disability Index v2 (ODI v2) Survey | To compare clinical outcomes among the three study arms utilizing the Oswestry Disability Idex (ODI) survey. This survey will be used to assess how back pain affects patients' ability to function in everyday life. Scores can range from 0% to 100% with higher scores indicating higher levels of disturbance in everyday life. | 3 months, 6 months, 12 months, 24 months |
| Bony Fusion Rates Compared Clinically Using the Short Form 36 Health Survey v2 (SF-36 v2) | To compare clinical outcomes among the three study arms utilizing the Short Form 36 Health Survey (SF-36). This survey will be used to assess patients' physical and mental health. Scores range from 0 to 100 with higher scores indicating better physical and mental health. | 3 months, 6 months, 12 months, 24 months |
Comparison of bony fusion rates at 12 and 24 months among the three study arms, using an X-ray based classification scale. |
| 12 months and 24 months |
| BG002 | Group 3 | Bilateral pedicle screws Pedicle Screw |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Group 3 |
Bilateral pedicle screws Pedicle Screw |
|
| Secondary | Bony Fusion Rates Compared Clinically Using the Visual Analog Scale (VAS) Survey | To compare clinical outcomes among the three study arms utilizing the Visual Analog Scale (VAS) survey. Visual analog scales will be used to assess neck, back, arm, and leg pain. Scores can range from 0 - 10 with higher scores indicating higher levels of pain. | Research has been discontinued. Data not collected and therefore not analyzed. | Posted | 3 months, 6 months, 12 months, 24 months |
|
|
| Secondary | Bony Fusion Rates Compared Clinically Using the Oswestry Disability Index v2 (ODI v2) Survey | To compare clinical outcomes among the three study arms utilizing the Oswestry Disability Idex (ODI) survey. This survey will be used to assess how back pain affects patients' ability to function in everyday life. Scores can range from 0% to 100% with higher scores indicating higher levels of disturbance in everyday life. | Research has been discontinued. Data not collected and therefore not analyzed. | Posted | 3 months, 6 months, 12 months, 24 months |
|
|
| Secondary | Bony Fusion Rates Compared Clinically Using the Short Form 36 Health Survey v2 (SF-36 v2) | To compare clinical outcomes among the three study arms utilizing the Short Form 36 Health Survey (SF-36). This survey will be used to assess patients' physical and mental health. Scores range from 0 to 100 with higher scores indicating better physical and mental health. | Research has been discontinued. Data not collected and therefore not analyzed. | Posted | 3 months, 6 months, 12 months, 24 months |
|
|
| Other Pre-specified | Safety Outcome: Immediate and Delayed Medical and Surgical Complications Compared Among the Three Arms | Immediate and delayed medical and surgical (including neurological) complications among the three study arms will be compared. | Research has been discontinued. Data not collected and therefore not analyzed. | Posted | post-surgery, 6 weeks, 3 months, 6 months, 12 months, 24 months |
|
|
| Other Pre-specified | Exploratory Outcome: Compare Bony Fusion Rates Using X-ray Based Classification Scale | Comparison of bony fusion rates at 12 and 24 months among the three study arms, using an X-ray based classification scale. | Research has been discontinued. Data not collected and therefore not analyzed. | Posted | 12 months and 24 months |
|
|
| 5 |
| 1 |
| 5 |
| 2 |
| 5 |
| EG001 | Group 2 | Ipsilateral pedicle screws, contralateral facet screw Pedicle Screw | 0 | 4 | 1 | 4 | 2 | 4 |
| EG002 | Group 3 | Bilateral pedicle screws Pedicle Screw | 0 | 6 | 1 | 6 | 4 | 6 |
|
| Bilateral PEs | Vascular disorders | Non-systematic Assessment | Subject self presented to hospital with SOB-Dyspnea leading to a diagnosis of bilateral PEs. Subject transferred and admitted to ED |
|
| Disc Herniation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient called in with increased back and leg pain after lifting a washing machine. The CNP advised imaging studies (X-rays and MRI) leading to a diagnosis of a disc herniation. |
|
|
| Allergic Reaction to dilaudid | Immune system disorders | Non-systematic Assessment | Intubated- Medical Management |
|
| ED Visit - Bronchitis/asthma attack | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Given Prednisone |
|
| RTC Impingement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | ESIs |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Narcan given |
|
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| D009984 |
| Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D053831 | Surgical Fixation Devices |