Evaluation of Surgical Treatment on Pain and Disability for Chronic, Non-healing Rib Fracture

This study has been completed.
Sponsor:
Collaborator:
ACUTE Innovations, LLC
Information provided by (Responsible Party):
John C. Mayberry, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00774618
First received: October 16, 2008
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

Individuals with non-healing rib fractures may experience significant pain and disability. This is called rib fracture non-union, an unusual problem and one that most physicians have little experience with. The investigators hypothesize that surgical repair of rib fracture non-union is clinically efficacious and safe in 6 month follow-up. The objective of this study is to evaluate how repairing non-healing rib fractures affects pain and disability.


Condition Intervention Phase
Rib Fracture
Device: Resection with or without plate fixation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Prospective Trial of Operative Management of Rib Fracture Non-Union

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluation of employment or disability status [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life evaluation [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ] [ Designated as safety issue: No ]
    (Rand 36-Item Short Form Health Survey)

  • an assessment of rib fracture pain [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ] [ Designated as safety issue: No ]
    McGill Pain Questionnaire or MPQ

  • complications related to injury or treatment [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: October 2008
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resection
Those subjects undergoing resection with or without plate fixation
Device: Resection with or without plate fixation
Some enrolled subjects will undergo rib fracture surgery at OHSU. Devices used in the repair of rib fracture non-union could include RibLoc® or BioBridge ™. RibLoc® is a U-shaped permanent device that secures to the rib with screws locking from the front to the back of the metal plate (through the rib). BioBridge ™ is a resorbable, non-permanent device that stabilizes the ribs. Both devices are designed to stabilize the rib fracture non-union and promote healing of the non-union rib. For some patients, it may be determined that resection of the rib fracture non-union without an implanted device is the most appropriate treatment. The goal of surgical intervention is to improve the pain and disability associated with rib fracture non-union in appropriate patients.
No Intervention: Nonoperative
These patients were not considered candidates for surgical intervention by the investigators, declined surgical intervention, or did not receive insurance approval for 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 350,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2006. The Healthcare Cost and Utilization Project's Nationwide Inpatient Sample for the year 2003 indicated that 102,000 patients with rib fractures were admitted to U.S. hospitals, representing 7 % of all injured patients.

Within the past decade a subgroup of patients with symptomatic rib fracture non-unions has been identified. These are patients who present to primary care physicians and surgical clinics more than 3 months, or in some cases several years, following a rib fracture injury with complaints of rib pain associated with persistent fracture movement. They are usually told by their physician that surgical intervention is either unnecessary or fruitless and are treated with chronic pain management regimens. The true incidence and the long-term outcome of this syndrome are completely unknown.

At OHSU, the investigators have had a long interest in the indications for and the outcomes of rib fracture repair. One of the first of three nearly simultaneous reports of successful surgical intervention of symptomatic rib fracture non-union originated here at OHSU in 2001. Two other successful case reports have appeared more recently. The investigators are currently being contacted frequently by patients or their physicians, mostly out of state, for consideration of rib fracture non-union repair. Our ongoing experience with rib fracture non-union repair has been favorable, but the investigators believe that a prospective clinical study with at least 6 months of post-operative outcome is necessary. In addition, because the insurance company approval process for surgical intervention for rib fracture non-union is often 2 - 3 months and occasionally longer, the investigators have an opportunity to follow the intermediate-term natural history of rib fracture non-unions for several months prior to surgical intervention.

The rationale for conducting this study is to demonstrate in a prospective study that the RibLoc ® repair system is durable and safe in a population of patients with rib fracture non-union. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that to establish the clinical benefit of the RibLoc ® device for non-union repair, prospectively collected outcome data are necessary. Investigators may use other FDA approved devices (i.e. BioBridge ™ Bioresorbable Bone Fracture Plate), or determine that no device is indicated (i.e. rib resection without hardware). The investigators expect to learn about clinical outcomes for surgical care in this group of patients, both with the use of a device, and without.

  Eligibility

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

Inclusion Criteria:

  1. Subjects must be at least 18 years of age
  2. Subjects must have rib fracture non-union (3 months or greater since injury), confirmed with Chest CT or MRI
  3. The subject will have signed an IRB approved written informed consent and HIPAA authorization to participate in the study
  4. Subjects will be able to participate in interviews with study staff and complete study surveys reliably

Exclusion Criteria:

  1. Subjects who are enrolled in another investigational treatment trial
  2. Subjects who have received an investigational drug or device within 30 days of enrollment
  3. Female subjects who are pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774618

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, FACS Oregon Health and Science University
  More Information

Publications:
Responsible Party: John C. Mayberry, Professor of Surgery, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00774618     History of Changes
Other Study ID Numbers: IRB e4073
Study First Received: October 16, 2008
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Rib Fracture
Thoracic Injuries
Flail Chest
Rib Fracture Repair
Rib Fracture ORIF
Chronic rib fractures
Non-healing rib fractures
Rib Fracture Non-union

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Ununited
Rib Fractures
Wounds and Injuries
Thoracic Injuries

ClinicalTrials.gov processed this record on April 17, 2014