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

Phase 4

Completed

• Conditions: Rib Fracture
• Interventions: Device: Resection with or without plate fixation

• Registration Number: NCT00774618
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-20
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Resection	Resection with or without plate fixation	Those subjects undergoing resection with or without plate fixation

Primary Outcome Measures

Name	Time	Method
Evaluation of employment or disability status	At study entry (day 1) and 2 month intervals for up to 12 months.

Secondary Outcome Measures

Name	Time	Method
quality of life evaluation	At study entry (day 1) and 2 month intervals for up to 12 months.	(Rand 36-Item Short Form Health Survey)
an assessment of rib fracture pain	At study entry (day 1) and 2 month intervals for up to 12 months.	McGill Pain Questionnaire or MPQ
complications related to injury or treatment	At study entry (day 1) and 2 month intervals for up to 12 months.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States