Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures

Conditions

Flail Chest, Rib Fracture

Keywords

Rib Fracture, Rib Fracture Repair, Rib Fracture ORIF, Flail Chest, Implant, Prosthesis, Rib fracture non-union, Chest wall deformity

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.

Related papers

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Interventions

DEVICEU-plate fracture repair system

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.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Subjects must be at least 18 years of age * Subjects must have one of the four clinical indications listed below: 1. 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 2. 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 3. 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 4. 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

Design outcomes

Primary

Measure	Time frame	Description
Adverse Post-op Events Related to the Repair and Plating System	180 days	Clinical evaluations or chest radiographs at a minimum of 1 and 6 months
The Rand 36-Item Health Survey Results - Physical Functioning Scale	results at 60, 120, and 180 days post-repair with results posted for 180 days	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	results at 60, 120, and 180 days post-repair with results posted for 180 days	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	results at 60, 120, and 180 days post-repair with results posted for 180 days	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	results at 60, 120, and 180 days post-repair with results posted for 180 days	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	results at 60, 120, and 180 days post-repair with results posted for 180 days	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	results at 60, 120, and 180 days post-repair with results posted for 180 days	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	results at 60, 120, and 180 days post-repair with results posted for 180 days	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	results at 60, 120, and 180 days post-repair with results posted for 180 days	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)	results at 60, 120, and 180 days post-repair with results posted for 180 days	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)	results at 60, 120, and 180 days post-repair with results posted for 180 days	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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

6 of the consented study participants had acute rib fractures, 4 had chronic rib fracture non-unions.

Participants by arm

Arm	Count
All Study Subjects	10
Total	10

Baseline characteristics

Characteristic	All Study Subjects
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	2 Participants
Age, Categorical Between 18 and 65 years	8 Participants
Age Continuous	46.5 years STANDARD_DEVIATION 22.5
Rib Fracture Rib Fracture, Acute	6 Participants
Rib Fracture Rib Fracture, Chronic Non-Union	4 Participants
Sex: Female, Male Female	2 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 6	3 / 4
serious Total, serious adverse events	0 / 6	0 / 4

Outcome results

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

Time frame: 180 days

Population: Per Protocol

Arm	Measure	Value (NUMBER)
Acute Rib Fracture Repair	Adverse Post-op Events Related to the Repair and Plating System	1 Participants
Rib Fracture Repair for Persistent Rib Fracture Non-Union	Adverse Post-op Events Related to the Repair and Plating System	3 Participants

Comparison: Fisher's Exact Test with the null hypothesis that the proportion with adverse events was the same in both groups.p-value: 0.19Fisher Exact

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.