Clinical Trial: Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Application of Indocyanine Green Angiography for Closed Operative Calcaneus Fractures Requiring Extensile Lateral Incision

Brief Summary:

Researchers in the Orthopaedic surgery department at LSU Medical Center-Shreveport hope to learn if patterns of blood-flow around the incision site of patients undergoing surgery for heel-bone fractures can help predict whether complications will arise after a specific type of operation.The goals of this research study are to effectively answer as many of the following research questions as possible:

  1. Can a drug normally used to evaluate adequate blood flow in plastic surgery and tissue transfer be used to identify altered patterns of blood flow at the operative site of Calcaneus fractures, when compared to the uninjured extremity?
  2. Are changes in blood flow identifiable at the operative site post operatively?
  3. Are there certain patterns of blood flow present preoperatively or postoperatively that can predict wound complication?
  4. Can certain patterns of blood flow predict the location of slough or dehiscence after surgery?
  5. Does the incision site and its proximity to specific patterns of blood flow possibly predict wound complication?

The hypothesis is that the study drug will show a correlation between certain patterns of blood flow and whatever post-operative complications may arise.


Detailed Summary:

Fractures of the calcaneus comprise 2% of all adult fractures. These fractures make up 60% of all tarsal injuries, the majority of which are closed, displaced intra-articular fractures. Despite the injury's prevalence, dispute over the appropriate method of treatment remains ongoing. Several studies have shown that an open, surgical approach is superior to either a non-surgical or percutaneous approach with regard to restoring proper alignment and structure of the hindfoot, depending on the severity of the displacement, and provided that certain patient conditions do not preclude surgery. Adequately restoring hindfoot structure is paramount to good clinical outcome; not only is proper alignment integral for fully recovering physiological functionality, but also in preventing further complications such as subtalar arthritis that present commonly in malunited calcaneal fractures.

Though literature may show that open reduction and internal fixation (ORIF) techniques provide a better long term outcome of severely displaced intra-articular fractures, proponents of both non surgical and percutaneous approaches argue that the superiority of the outcome may be mitigated by the fact that open surgical procedures are laden post operatively with numerous wound complications. These complications include, but are not limited to, both deep and superficial infections resulting in slough, dehiscence, necrosis, and erythema in and around the surgical site. Managing infections of the surrounding soft tissue and vasculature of the calcaneus following operative treatment indeed seems to present a great challenge to treating physicians, with wound healing complications present in 2-25% of cases.

A necessity for surgical wound repair is adequately vascularized tissue, which can be difficult to come by during closure of the wound due to the unde
Sponsor: Louisiana State University Health Sciences Center Shreveport

Current Primary Outcome: a statistically relevant correlation between operative site perfusion patterns and development of wound healing complications post operatively. [ Time Frame: 12 weeks post operatively per patient ]

When 13 patients have enrolled and data collection has been finalized, if the statistician does not believe there is enough data to identify a statistically significant correlation, then the study will continue until 21 subjects have been enrolled. If at this time, there is still an inadequate amount of data for statistical significance, the study will continue until 28 subjects are enrolled. If, in the statistician's opinion, an intermediate value of subjects between the numbers given above will suffice for showing statistical significance, that will be the number enrolled. Every effort will be made to ensure that no more subjects will be enrolled than the minimum necessary to show statistical significance.


Original Primary Outcome: a statistically relevant correlation between operative site perfusion patterns and development of wound healing complications post operatively. [ Time Frame: Patient data will be recorded for follow up visits 2, 6, and 12 week post operative visits ]

When 13 patients have enrolled and data collection has been finalized, if the statistician does not believe there is enough data to identify a statistically significant correlation, then the study will continue until 21 subjects have been enrolled. If at this time, there is still an inadequate amount of data for statistical significance, the study will continue until 28 subjects are enrolled. If, in the statistician's opinion, an intermediate value of subjects between the numbers given above will suffice for showing statistical significance, that will be the number enrolled. Every effort will be made to ensure that no more subjects will be enrolled than the minimum necessary to show statistical significance.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Louisiana State University Health Sciences Center Shreveport

Dates:
Date Received: September 20, 2012
Date Started: April 2013
Date Completion:
Last Updated: September 16, 2016
Last Verified: March 2016