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| ID | Type | Description | Link |
|---|---|---|---|
| eIRB00000579 |
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| Name | Class |
|---|---|
| ACUTE Innovations, LLC | INDUSTRY |
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The purpose of this study is to gather information about a device used to help fix broken ribs.
Hypothesis: Rib fracture repair with the U-plate system is clinically durable and safe for the indications of flail chest repair, acute pain control, chest wall defect repair, and rib fracture non-union.
Rib fractures are a painful and disabling injury commonly found among trauma patients. According to the National Center for Health Statistics, approximately 300,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2004. Rib fracture patients are significantly more disabled at 30 days post-injury than patients with chronic medical illness and lose an average of 70 days of work or usual activity during their acute recovery.
The rationale for conducting this study is to demonstrate in a prospective study that the U-plate repair system is durable and safe. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that in order for the U-plate to be widely accepted, prospectively collected outcome data are necessary.
With the goal of improving the durability of fixation of rib fractures over the techniques currently available and with the additional goal of developing a minimally invasive technique, a U-shaped plate was developed. The design of the U-plate theoretically overcomes the inherent softness of the human rib by grasping the rib over its superior margin and by securing the plate with anterior to posterior locking screws that do not rely on screw purchase in bone. Thus much of the strength and durability of the fixation is transferred from the relatively soft rib to the plate itself.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| U-plate fracture repair system | Device | All subjects meeting inclusion criteria will undergo surgery for the repair of their fractured rib/s using the U-plate device. Subjects will be monitored daily during the entire course of their hospitalization for adverse experiences. Subjects will be contacted by phone to complete the MPQ and SF-36 Health Survey. Subjects will be asked if and when they have returned to work or to their previous level of functioning. Subjects will be asked if they had any complications or problems associated with their surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Post-op Events Related to the Repair and Plating System | Clinical evaluations or chest radiographs at a minimum of 1 and 6 months | 180 days |
| The Rand 36-Item Health Survey Results - Physical Functioning Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | results at 60, 120, and 180 days post-repair with results posted for 180 days |
| The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | results at 60, 120, and 180 days post-repair with results posted for 180 days |
| The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. |
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Inclusion Criteria:
Subjects must be at least 18 years of age
Subjects must have one of the four clinical indications listed below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C. Mayberry, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10697096 | Background | Cacchione RN, Richardson JD, Seligson D. Painful nonunion of multiple rib fractures managed by operative stabilization. J Trauma. 2000 Feb;48(2):319-21. doi: 10.1097/00005373-200002000-00023. No abstract available. | |
| 4037191 | Background | Beal SL, Oreskovich MR. Long-term disability associated with flail chest injury. Am J Surg. 1985 Sep;150(3):324-6. doi: 10.1016/0002-9610(85)90071-6. |
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6 of the consented study participants had acute rib fractures, 4 had chronic rib fracture non-unions.
10 Study subjects were enrolled to the study over a 10 month period in 2007 (February to November and underwent surgical repair of their rib fracture injury. All subjects were recruited from the OHSU Hospital and Outpatient Clinic.Study approval was granted on 11/18/2006 by the OHSU Research Integrity Office.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Adverse Post-op Events Related to the Repair and Plating System | Clinical evaluations or chest radiographs at a minimum of 1 and 6 months | Per Protocol | Posted | Mar 2011 | Number | Participants | 180 days |
|
Enrolled subjects were followed for 6 months following surgical repair of their rib fracture.
Subjects were evaluated with radiographic evaluations (chest x-rays) at a minimum of 1 and 6 months. Subjects completed the McGill Pain Questionnaire and the Rand 36 Health Survey at serial intervals during the 6 months of study participation.
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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 | Acute Rib Fracture Repair |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute repair adverse event | Infections and infestations | "Serious" and "Other | Systematic Assessment | There was 1 acute surgical site infection requiring surgical drainage that did not involve the plates. No plating system events occurred in acute fracture repairs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Mayberry, MD | Oregon Health & Science University | 503-494-5300 | mayberrj@ohsu.edu |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| D005409 | Flail Chest |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
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| results at 60, 120, and 180 days post-repair with results posted for 180 days |
| The Rand 36-Item Health Survey Results - Vitality Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | results at 60, 120, and 180 days post-repair with results posted for 180 days |
| The Rand 36-Item Health Survey Results - Emotional Well-being Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | results at 60, 120, and 180 days post-repair with results posted for 180 days |
| The Rand 36-Item Health Survey Results - Social Functioning Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | results at 60, 120, and 180 days post-repair with results posted for 180 days |
| The Rand 36-Item Health Survey Results - Bodily Pain Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | results at 60, 120, and 180 days post-repair with results posted for 180 days |
| The Rand 36-Item Health Survey Results - General Health Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | results at 60, 120, and 180 days post-repair with results posted for 180 days |
| The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI) | The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain. | results at 60, 120, and 180 days post-repair with results posted for 180 days |
| The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI) | The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain. | results at 60, 120, and 180 days post-repair with results posted for 180 days |
| 11956391 | Background | Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020. |
| 11587704 | Background | Ng AB, Giannoudis PV, Bismil Q, Hinsche AF, Smith RM. Operative stabilisation of painful non-united multiple rib fractures. Injury. 2001 Oct;32(8):637-9. doi: 10.1016/s0020-1383(01)00017-1. No abstract available. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Rib Fracture | Acute Rib Fracture: Subjects with 1. multiple rib fractures and flail chest injury with failure to wean from ventilator (>5 days post-injury, 2. painful, displaced rib fractures who do not receive adequate pain control from usual care, and 3. chest wall defect (visible deformity) / severely displaced rib fractures will be included. Subjects who have sustained a severe head injury or those with extensive associated injuries will not be included. Chronic Rib Fracture Non-Union: Subjects with CT evidence of non-healed rib fractures > 2 months from time of injury, with rib pain. | Number | Participants |
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| Primary | The Rand 36-Item Health Survey Results - Physical Functioning Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | Per Protocol | Posted | Mean | Standard Deviation | RAND-36 scale units | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| Primary | The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | Per Protocol | Posted | Mean | Standard Deviation | RAND-36 scale units | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| Primary | The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | Per Protocol | Posted | Mean | Standard Deviation | RAND-36 scale units | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| Primary | The Rand 36-Item Health Survey Results - Vitality Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | Per Protocol | Posted | Mean | Standard Deviation | RAND-36 scale units | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| Primary | The Rand 36-Item Health Survey Results - Emotional Well-being Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | Per Protocol | Posted | Mean | Standard Deviation | RAND-36 scale units | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| Primary | The Rand 36-Item Health Survey Results - Social Functioning Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | Per Protocol | Posted | Mean | Standard Deviation | RAND-36 scale units | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| Primary | The Rand 36-Item Health Survey Results - Bodily Pain Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | Per Protocol | Posted | Mean | Standard Deviation | RAND-36 scale units | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| Primary | The Rand 36-Item Health Survey Results - General Health Scale | The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study. | Per Protocol | Posted | Mean | Standard Deviation | RAND-36 scale units | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| Primary | The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI) | The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain. | Per Protocol | Posted | Mean | Standard Deviation | PPI | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| Primary | The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI) | The MPQ evaluates subjective pain using word descriptors (PPI, present pain intensity) and an intensity scale (PRI, pain rating index). The rank value for each word descriptor is based on its position in the word set. The sum of the rank values is the pain rating index (PPI). The maximum pain score using word descriptors is 78, with a higher score reflecting greater pain. | Per Protocol | Posted | Mean | Standard Deviation | PRI | results at 60, 120, and 180 days post-repair with results posted for 180 days |
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| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Chronic Rib Fracture Non-union Repair | 0 | 4 | 3 | 4 |
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| Chronic non-union repair | Surgical and medical procedures | "Serious" and "Other | Systematic Assessment | Subject with minimal screw backout on imaging. The subject was asymptomatic and did not require reoperation. |
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| Chronic non-union repair | Surgical and medical procedures | "Serious" and "Other | Systematic Assessment | Subject experienced complete backout of one screw. The subject was asymptomatic and did not require reoperation. |
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| Chronic non-union repair | Surgical and medical procedures | "Serious" and "Other | Systematic Assessment | Subject experienced breakage of one metal plate. Plate failure was determined with a chest x-ray. The subject was asymptomatic and did not require reoperation. |
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