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

NCT00774618 | Completed Phase 4 DMC

• 1 other identifier: IRB e4073
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fracture

Keywords

Rib Fracture; Thoracic Injuries; Flail Chest; Rib Fracture Repair; Rib Fracture ORIF; Chronic rib fractures; Non-healing rib fractures; Rib Fracture Non-union

Outcome Measures

Primary Outcomes (1)

• Evaluation of employment or disability status

  At study entry (day 1) and 2 month intervals for up to 12 months.

Secondary Outcomes (3)

• quality of life evaluation

  At study entry (day 1) and 2 month intervals for up to 12 months.

• an assessment of rib fracture pain

  At study entry (day 1) and 2 month intervals for up to 12 months.

• complications related to injury or treatment

  At study entry (day 1) and 2 month intervals for up to 12 months.

Study Arms (2)

Resection

EXPERIMENTAL

Those subjects undergoing resection with or without plate fixation

Device: Resection with or without plate fixation

Nonoperative

NO INTERVENTION

These patients were not considered candidates for surgical intervention by the investigators, declined surgical intervention, or did not receive insurance approval for surgery

Interventions

Resection with or without plate fixation DEVICE

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.

Resection

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 rib fracture non-union (3 months or greater since injury), confirmed with Chest CT or MRI
• The subject will have signed an IRB approved written informed consent and HIPAA authorization to participate in the study
• Subjects will be able to participate in interviews with study staff and complete study surveys reliably

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
• Female subjects who are pregnant

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 (7)

• 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

• 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

• Slater MS, Mayberry JC, Trunkey DD. Operative stabilization of a flail chest six years after injury. Ann Thorac Surg. 2001 Aug;72(2):600-1. doi: 10.1016/s0003-4975(00)02262-1.

  PMID: 11515905 BACKGROUND

• Beelen R, Rumbaut J, De Geest R. Surgical stabilization of a rib fracture using an angle stable plate. J Trauma. 2007 Nov;63(5):1159-60. doi: 10.1097/01.ta.0000222536.91745.b4. No abstract available.

  PMID: 17514061 BACKGROUND

• Richardson JD, Franklin GA, Heffley S, Seligson D. Operative fixation of chest wall fractures: an underused procedure? Am Surg. 2007 Jun;73(6):591-6; discussion 596-7.

  PMID: 17658097 BACKGROUND

• Sales JR, Ellis TJ, Gillard J, Liu Q, Chen JC, Ham B, Mayberry JC. Biomechanical testing of a novel, minimally invasive rib fracture plating system. J Trauma. 2008 May;64(5):1270-4. doi: 10.1097/TA.0b013e31804a7fd5.

  PMID: 18469649 BACKGROUND

• Nirula R, Diaz JJ Jr, Trunkey DD, Mayberry JC. Rib fracture repair: indications, technical issues, and future directions. World J Surg. 2009 Jan;33(1):14-22. doi: 10.1007/s00268-008-9770-y.

  PMID: 18949513 BACKGROUND

MeSH Terms

Conditions

Rib Fractures; Thoracic Injuries; Flail Chest

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• John C Mayberry, MD, FACS

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

US (1)