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

NCT00556543 | Completed Results DMC

• 2 other identifiers: IRB 579eIRB00000579
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fracture; Flail Chest

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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.

  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

Study Arms (1)

Treatment

OTHER

Device: U-plate fracture repair system

Interventions

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• ACUTE Innovations, LLC: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (4)

• 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.

  PMID: 10697096 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.

  PMID: 4037191 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.

  PMID: 11956391 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.

  PMID: 11587704 BACKGROUND

MeSH Terms

Conditions

Rib Fractures; Flail Chest

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Results Point of Contact

• Title: John Mayberry, MD
• Organization: Oregon Health & Science University

mayberrj@ohsu.edu

503-494-5300

Study Officials

• John C. Mayberry, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: November 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 1, 2011
• Results First Posted: May 10, 2011

Record last verified: 2011-06

Locations

US (1)