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

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00556543
• Collaborator: ACUTE Innovations, LLC (Industry)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rib Fracture; Flail Chest	Device: U-plate fracture repair system	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the U-plate Fracture Repair System for the Fixation of Rib Fractures
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Beal SL, Oreskovich MR. Long-term disability associated with flail chest injury. Am J Surg. 1985 Sep;150(3):324-6.
• Cacchione RN, Richardson JD, Seligson D. Painful nonunion of multiple rib fractures managed by operative stabilization. J Trauma. 2000 Feb;48(2):319-21.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00556543
• Other Study ID Numbers: IRB 579; eIRB00000579
• First Posted: Nov 12, 2007
• Last Update Posted: Jul 1, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: Rib Fracture; Rib Fracture Repair; Rib Fracture ORIF; Flail Chest; Implant; Prosthesis; Rib fracture non-union; Chest wall deformity
• Additional relevant MeSH terms: Fractures, Bone; Rib Fractures; Flail Chest

Study Results

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

Arm/Group Title	All Study Subjects
Arm/Group Description
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	All Study Subjects
Arm/Group Description
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 80%
>=65 years	2 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.5 (22.5)
Sex: Female, Male (Count of Participants)
Female	2 20%
Male	8 80%
Rib Fracture (Number) [Number]
Rib Fracture, Acute	6 60%
Rib Fracture, Chronic Non-Union	4 40%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	Acute Rib Fracture Repair	Rib Fracture Repair for Persistent Rib Fracture Non-Union
Arm/Group Description	These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 - 18 days) post-injury.	Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 - 56 months) post-injury at the time of repair.
Measure Participants	6	4
Number [Participants]	1 10%	3 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acute Rib Fracture Repair, Rib Fracture Repair for Persistent Rib Fracture Non-Union
	Comments	Fisher's Exact Test with the null hypothesis that the proportion with adverse events was the same in both groups.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	No power calculation performed.
Statistical Test of Hypothesis	p-Value	0.190
	Comments
	Method	Fisher Exact
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [RAND-36 scale units]	65.6 (22.8)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [RAND-36 scale units]	33.3 (35.4)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [RAND-36 scale units]	81.4 (37.7)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [RAND-36 scale units]	57.2 (18.9)

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [RAND-36 scale units]	73.3 (13.1)

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [RAND-36 scale units]	76.4 (25.3)

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [RAND-36 scale units]	66.0 (24.4)

9. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [RAND-36 scale units]	62.2 (20.8)

10. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [PPI]	1.22 (0.97)

11. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Per Protocol

Arm/Group Title	All Study Subjects
Arm/Group Description
Measure Participants	10
Mean (Standard Deviation) [PRI]	17.78 (15.58)

Adverse Events

Time Frame	Enrolled subjects were followed for 6 months following surgical repair of their rib fracture.
Adverse Event Reporting Description	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.
Arm/Group Title	Acute Rib Fracture Repair		Chronic Rib Fracture Non-union Repair
Arm/Group Description
All Cause Mortality
	Acute Rib Fracture Repair		Chronic Rib Fracture Non-union Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Acute Rib Fracture Repair		Chronic Rib Fracture Non-union Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Acute Rib Fracture Repair		Chronic Rib Fracture Non-union Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)		3/4 (75%)
Infections and infestations
Acute repair adverse event	1/6 (16.7%)	1	0/0 (NaN)	0
Surgical and medical procedures
Chronic non-union repair	0/0 (NaN)	0	1/4 (25%)	1
Chronic non-union repair	0/0 (NaN)	0	1/4 (25%)	1
Chronic non-union repair	0/0 (NaN)	0	1/4 (25%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.