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

Purpose

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.

Condition	Intervention
Rib Fracture Flail Chest	Device: U-plate fracture repair system

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Evaluation of the U-plate Fracture Repair System for the Fixation of Rib Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Adverse Post-op Events Related to the Repair and Plating System [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Clinical evaluations or chest radiographs at a minimum of 1 and 6 months
The Rand 36-Item Health Survey Results - Physical Functioning Scale [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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 [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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 [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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 [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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 [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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 [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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 [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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 [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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) [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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) [ Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days ] [ Designated as safety issue: No ]
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.

Enrollment:	10
Study Start Date:	November 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment	Device: U-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.

Arms

Assigned Interventions

Treatment

Device: U-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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556543

Locations

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

ACUTE Innovations, LLC

Investigators

Principal Investigator:

John C. Mayberry, MD

Oregon Health and Science University

More Information

Publications:

Cacchione RN, Richardson JD, Seligson D. Painful nonunion of multiple rib fractures managed by operative stabilization. J Trauma. 2000 Feb;48(2):319-21. No abstract available.

Beal SL, Oreskovich MR. Long-term disability associated with flail chest injury. Am J Surg. 1985 Sep;150(3):324-6.

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.

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. No abstract available.

Responsible Party:	John Mayberry, MD, Oregon Health & Science University
ClinicalTrials.gov Identifier:	NCT00556543 History of Changes
Other Study ID Numbers:	IRB 579, eIRB00000579
Study First Received:	November 9, 2007
Results First Received:	March 17, 2011
Last Updated:	June 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Rib Fracture
Rib Fracture Repair
Rib Fracture ORIF
Flail Chest

Implant
Prosthesis
Rib fracture non-union
Chest wall deformity

Additional relevant MeSH terms:

Flail Chest
Fractures, Bone
Rib Fractures
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013