Back to resultsClinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures
Primary Purpose
Rib Fracture, Flail Chest
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
U-plate fracture repair system
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fracture focused on measuring Rib Fracture, Rib Fracture Repair, Rib Fracture ORIF, Flail Chest, Implant, Prosthesis, Rib fracture non-union, Chest wall deformity
Eligibility Criteria
Inclusion Criteria:
- Subjects must be at least 18 years of age
Subjects must have one of the four clinical indications listed below:
- Flail chest with failure to wean from ventilator (> 5 days post-injury) and Paradoxical chest wall movement visualized; no significant pulmonary contusion and no significant brain injury
- Painful, displaced rib fractures (acute pain control) and failure of narcotics or epidural pain catheter to control pain; fracture movement exacerbates pain (after 7 - 10 days) and minimal associated injuries
- Chest wall defect/severely displaced fractures and non-repair defect may result in pulmonary hernia and severely displaced fractures are significantly impeding lung expansion in hemi-thorax
- Symptomatic rib fracture non-union and CT scan evidence of fracture non-union at least 2 months post-injury
Exclusion Criteria:
- Subjects who are enrolled in another investigational treatment trial
- Subjects who have received an investigational drug or device within 30 days of enrollment
- Subjects who are unable to complete the follow-up questionnaires
- Subjects with severe head injuries or other severe associated injuries
- Subjects who are not expected to survive the follow-up period
- Female subjects who are pregnant
- Non-English or English as Second Language speakers
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Adverse Post-op Events Related to the Repair and Plating System
Clinical evaluations or chest radiographs at a minimum of 1 and 6 months
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00556543
First Posted
November 9, 2007
Last Updated
June 7, 2011
Sponsor
Oregon Health and Science University
Collaborators
ACUTE Innovations, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00556543
Brief Title
Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures
Official Title
Clinical Evaluation of the U-plate Fracture Repair System for the Fixation of Rib Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oregon Health and Science University
Collaborators
ACUTE Innovations, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fracture, Flail Chest
Keywords
Rib Fracture, Rib Fracture Repair, Rib Fracture ORIF, Flail Chest, Implant, Prosthesis, Rib fracture non-union, Chest wall deformity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
U-plate fracture repair system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Post-op Events Related to the Repair and Plating System
Description
Clinical evaluations or chest radiographs at a minimum of 1 and 6 months
Time Frame
180 days
Title
The Rand 36-Item Health Survey Results - Physical Functioning Scale
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
Title
The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
Title
The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
Title
The Rand 36-Item Health Survey Results - Vitality Scale
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
Title
The Rand 36-Item Health Survey Results - Emotional Well-being Scale
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
Title
The Rand 36-Item Health Survey Results - Social Functioning Scale
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
Title
The Rand 36-Item Health Survey Results - Bodily Pain Scale
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
Title
The Rand 36-Item Health Survey Results - General Health Scale
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
Title
The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
Title
The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)
Description
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.
Time Frame
results at 60, 120, and 180 days post-repair with results posted for 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be at least 18 years of age
Subjects must have one of the four clinical indications listed below:
Flail chest with failure to wean from ventilator (> 5 days post-injury) and Paradoxical chest wall movement visualized; no significant pulmonary contusion and no significant brain injury
Painful, displaced rib fractures (acute pain control) and failure of narcotics or epidural pain catheter to control pain; fracture movement exacerbates pain (after 7 - 10 days) and minimal associated injuries
Chest wall defect/severely displaced fractures and non-repair defect may result in pulmonary hernia and severely displaced fractures are significantly impeding lung expansion in hemi-thorax
Symptomatic rib fracture non-union and CT scan evidence of fracture non-union at least 2 months post-injury
Exclusion Criteria:
Subjects who are enrolled in another investigational treatment trial
Subjects who have received an investigational drug or device within 30 days of enrollment
Subjects who are unable to complete the follow-up questionnaires
Subjects with severe head injuries or other severe associated injuries
Subjects who are not expected to survive the follow-up period
Female subjects who are pregnant
Non-English or English as Second Language speakers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Mayberry, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10697096
Citation
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.
Results Reference
background
PubMed Identifier
4037191
Citation
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.
Results Reference
background
PubMed Identifier
11956391
Citation
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.
Results Reference
background
PubMed Identifier
11587704
Citation
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.
Results Reference
background
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Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures
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