CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Resection with or without plate fixationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00774618
NCT00774618Phase 4Completed
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Prospective Trial of Operative Management of Rib Fracture Non-Union

Oregon Health and Science University·interventional·Posted Oct 17, 2008·Updated Mar 22, 2013

In Brief

A Phase 4 clinical trial evaluating Resection with or without plate fixation for Rib Fracture. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRib Fracture
CountriesUnited States
CollaboratorsACUTE Innovations, LLC

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2008
Enrollment StartOct 1, 2008
Primary CompletionAug 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.7 years ago

Interventions

Resection with or without plate fixationdevice

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.