Clinical trial NCT00556543: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: ACUTE Innovations, LLC
First posted: 2007-11-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Adverse Post-op Events Related to the Repair and Plating System
timeFrame: 180 days
measure: The Rand 36-Item Health Survey Results - Physical Functioning Scale
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
measure: The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
measure: The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
measure: The Rand 36-Item Health Survey Results - Vitality Scale
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
measure: The Rand 36-Item Health Survey Results - Emotional Well-being Scale
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
measure: The Rand 36-Item Health Survey Results - Social Functioning Scale
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
measure: The Rand 36-Item Health Survey Results - Bodily Pain Scale
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
measure: The Rand 36-Item Health Survey Results - General Health Scale
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
measure: The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
measure: The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)
timeFrame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: John C. Mayberry, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.