Operative and Non-operative Treatment of Traumatic Arthrotomies
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/16/2018 |
Start Date: | April 2015 |
End Date: | April 2020 |
Contact: | Christine Churchilll, MA |
Email: | Christine.Churchill@carolinashealthcare.org |
Phone: | 704-355-6947 |
Operative and Non-operative Treatment of Traumatic Arthrotomies: A Prospective Observational Study
For the last 70 years, orthopaedic dogma has dictated that all injuries that penetrate the
joint capsule require formal irrigation and debridement in the operating room to minimize the
risk of developing septic complications. The literature supporting this practice is sparse
and stems primarily from wartime injuries that may not be generalizable to the smaller, less
contaminated arthrotomies seen in the civilian population. Despite the classical teaching of
all traumatic arthrotomies requiring irrigation, debridement, and closure in the operating
room, numerous surgeons around the country are beginning to treat small traumatic
arthrotomies without surgery. The purpose of this study is to evaluate the cost of treatment
as well as incidence of adverse events, such as the development of septic arthritis, in
patients undergoing operative and non-operative treatment of traumatic arthrotomies.
joint capsule require formal irrigation and debridement in the operating room to minimize the
risk of developing septic complications. The literature supporting this practice is sparse
and stems primarily from wartime injuries that may not be generalizable to the smaller, less
contaminated arthrotomies seen in the civilian population. Despite the classical teaching of
all traumatic arthrotomies requiring irrigation, debridement, and closure in the operating
room, numerous surgeons around the country are beginning to treat small traumatic
arthrotomies without surgery. The purpose of this study is to evaluate the cost of treatment
as well as incidence of adverse events, such as the development of septic arthritis, in
patients undergoing operative and non-operative treatment of traumatic arthrotomies.
Background and Rationale Soft tissue wounds around joints are common injuries that are
carefully evaluated to identify intra-articular extension. Wound exploration, imaging, and
intra-articular saline load injections are commonly utilized to diagnose the presence of a
traumatic arthrotomy. The reason for such diligence is that the treatment is dramatically
different for a wound that violates the joint compared to one that does not. As opposed to
local wound care for simple soft tissue wounds, traumatic arthrotomies are thought to require
formal irrigation and debridement in the operating room to minimize the risk of developing
septic arthritis.
Septic Joints An injury that penetrates the joint capsule and synovium violates the body's
natural barriers that protect the joint from external pathogens. Microorganisms from the
environment may enter the joint by direct inoculation or by contiguous spread through the now
perforated barrier. By bringing patients to the operating room for formal irrigation and
debridement, orthopaedic surgeons are theoretically attempting to minimize the burden of
contamination and repair the body's natural barriers to reduce the risk of developing an
intra-articular infection. Septic arthritis is an orthopaedic emergency that can result in
severe cartilage damage causing long-term joint pain, stiffness, and potentially auto-fusion.
If not dealt with in a timely manner, intra-articular infections can result in significant
long-term disability, and in extreme cases, can result in overwhelming sepsis and death.
Orthopaedic Dogma Clearly, minimizing the risk of developing septic arthritis is important to
every orthopaedic surgeon. Over sixty years ago, observation of a high rate of septic
complications in combat injuries that violated the joint. Since then, orthopaedic dogma has
dictated that all injuries that violate the joint necessitate formal irrigation and
debridement in order to minimize the risk of infectious complications. The literature on the
topic is sparse and stems primarily from wartime observations in which the injuries sustained
were commonly associated with high levels of contamination, intra-articular fractures,
retained foreign bodies, and delayed treatment. The characteristics of these injuries may
limit the generalizability of these observations to the civilian population, especially for
small, mildly contaminated arthrotomies without associated fracture or retained foreign body.
To date, no studies have prospectively evaluated the benefits of operative irrigation and
debridement of traumatic arthrotomies compared to non-operative observation with antibiotics.
A single study published showed that patients with open joint injuries treated with operative
irrigation and debridement had an infection rate of 2.1%, a value significantly lower than
was previously observed in the non-operative cohort of combat injuries. There is little
question that large and heavily contaminated arthrotomies benefit from formal irrigation and
debridement, but it is unclear if this benefit can extrapolated to smaller, less contaminated
injuries. Nevertheless, orthopaedic surgeons continue to debride and irrigate open joints
regardless of the burden of contamination or size of arthrotomy.
Small Arthrotomies are Commonly Missed Injuries In an effort to identify and treat as many
traumatic arthrotomies as possible, orthopaedic surgeons began looking for additional
techniques to aid in their diagnosis. After it's introduction in 1975, saline arthrograms
quickly became the gold standard for the diagnosis of small traumatic arthrotomies. This
doctrine was called into question when they showed that saline load arthrograms, as they were
commonly performed, had a sensitivity of only 43%. Two years later, it was recommended using
155-ml of saline to diagnose 95% of arthrotomies, a volume more than double what was previous
used in clinical practice and not easily tolerated by most patients. Most recently, a study
showed a false-negative rate of 67% when using 180-mL of saline for their arthrograms, a
volume far beyond what would be tolerated in a conscious patient. Despite missing up to half
of all small traumatic arthrotomies for the last 40 years, there has not been an outbreak in
patients returning with septic arthritis from missed arthrotomies. The absence of such an
occurrence raises the question if it is even necessary to formally debride and irrigate small
traumatic arthrotomies in the operating room at a great cost to the patient.
Costs of Arthrotomy Despite the relative dearth of evidence supporting the practice of
formally irrigating and debriding all open joint injuries, significant healthcare
expenditures and additional risks of general anesthesia are undertaken to address this
problem. Although the administration of general anesthesia has become extremely safe, it
still carries the risk of serious consequences such as heart attack, stroke, and even death.
Patients with multiple medical comorbidities are at an even greater risk of a serious
perioperative complication.
In addition to the risks of undergoing anesthesia, there are significant costs associated
with any operation. A patient diagnosed with an isolated traumatic knee arthrotomy can expect
to leave the hospital with a bill of at least $15,000 based on conservative estimates
provided by the Department of Research Finance at Carolinas Medical Center. In an era where
healthcare costs are spiraling out of control, determining which interventions are
efficacious will be paramount in shaping healthcare resource utilization and maintaining
long-term sustainability.
Specific Aims:
1. To compare the cost of medical care in patients with traumatic arthrotomies treated with
surgical irrigation and debridement versus non-operative treatment with local wound
care.
2. To determine the incidence of developing a septic arthritis in patients with a
non-operatively treated traumatic arthrotomy.
3. To determine the incidence of developing a septic arthritis in patients with operative
treatment of a traumatic arthrotomy.
4. To determine the need for additional surgery (ex: foreign body removal) in patients with
a non-operatively treated traumatic arthrotomy.
5. To provide a description of traumatic arthrotomies successfully treated non-operatively.
Study Design Prospective Multi-center Observational Cohort
carefully evaluated to identify intra-articular extension. Wound exploration, imaging, and
intra-articular saline load injections are commonly utilized to diagnose the presence of a
traumatic arthrotomy. The reason for such diligence is that the treatment is dramatically
different for a wound that violates the joint compared to one that does not. As opposed to
local wound care for simple soft tissue wounds, traumatic arthrotomies are thought to require
formal irrigation and debridement in the operating room to minimize the risk of developing
septic arthritis.
Septic Joints An injury that penetrates the joint capsule and synovium violates the body's
natural barriers that protect the joint from external pathogens. Microorganisms from the
environment may enter the joint by direct inoculation or by contiguous spread through the now
perforated barrier. By bringing patients to the operating room for formal irrigation and
debridement, orthopaedic surgeons are theoretically attempting to minimize the burden of
contamination and repair the body's natural barriers to reduce the risk of developing an
intra-articular infection. Septic arthritis is an orthopaedic emergency that can result in
severe cartilage damage causing long-term joint pain, stiffness, and potentially auto-fusion.
If not dealt with in a timely manner, intra-articular infections can result in significant
long-term disability, and in extreme cases, can result in overwhelming sepsis and death.
Orthopaedic Dogma Clearly, minimizing the risk of developing septic arthritis is important to
every orthopaedic surgeon. Over sixty years ago, observation of a high rate of septic
complications in combat injuries that violated the joint. Since then, orthopaedic dogma has
dictated that all injuries that violate the joint necessitate formal irrigation and
debridement in order to minimize the risk of infectious complications. The literature on the
topic is sparse and stems primarily from wartime observations in which the injuries sustained
were commonly associated with high levels of contamination, intra-articular fractures,
retained foreign bodies, and delayed treatment. The characteristics of these injuries may
limit the generalizability of these observations to the civilian population, especially for
small, mildly contaminated arthrotomies without associated fracture or retained foreign body.
To date, no studies have prospectively evaluated the benefits of operative irrigation and
debridement of traumatic arthrotomies compared to non-operative observation with antibiotics.
A single study published showed that patients with open joint injuries treated with operative
irrigation and debridement had an infection rate of 2.1%, a value significantly lower than
was previously observed in the non-operative cohort of combat injuries. There is little
question that large and heavily contaminated arthrotomies benefit from formal irrigation and
debridement, but it is unclear if this benefit can extrapolated to smaller, less contaminated
injuries. Nevertheless, orthopaedic surgeons continue to debride and irrigate open joints
regardless of the burden of contamination or size of arthrotomy.
Small Arthrotomies are Commonly Missed Injuries In an effort to identify and treat as many
traumatic arthrotomies as possible, orthopaedic surgeons began looking for additional
techniques to aid in their diagnosis. After it's introduction in 1975, saline arthrograms
quickly became the gold standard for the diagnosis of small traumatic arthrotomies. This
doctrine was called into question when they showed that saline load arthrograms, as they were
commonly performed, had a sensitivity of only 43%. Two years later, it was recommended using
155-ml of saline to diagnose 95% of arthrotomies, a volume more than double what was previous
used in clinical practice and not easily tolerated by most patients. Most recently, a study
showed a false-negative rate of 67% when using 180-mL of saline for their arthrograms, a
volume far beyond what would be tolerated in a conscious patient. Despite missing up to half
of all small traumatic arthrotomies for the last 40 years, there has not been an outbreak in
patients returning with septic arthritis from missed arthrotomies. The absence of such an
occurrence raises the question if it is even necessary to formally debride and irrigate small
traumatic arthrotomies in the operating room at a great cost to the patient.
Costs of Arthrotomy Despite the relative dearth of evidence supporting the practice of
formally irrigating and debriding all open joint injuries, significant healthcare
expenditures and additional risks of general anesthesia are undertaken to address this
problem. Although the administration of general anesthesia has become extremely safe, it
still carries the risk of serious consequences such as heart attack, stroke, and even death.
Patients with multiple medical comorbidities are at an even greater risk of a serious
perioperative complication.
In addition to the risks of undergoing anesthesia, there are significant costs associated
with any operation. A patient diagnosed with an isolated traumatic knee arthrotomy can expect
to leave the hospital with a bill of at least $15,000 based on conservative estimates
provided by the Department of Research Finance at Carolinas Medical Center. In an era where
healthcare costs are spiraling out of control, determining which interventions are
efficacious will be paramount in shaping healthcare resource utilization and maintaining
long-term sustainability.
Specific Aims:
1. To compare the cost of medical care in patients with traumatic arthrotomies treated with
surgical irrigation and debridement versus non-operative treatment with local wound
care.
2. To determine the incidence of developing a septic arthritis in patients with a
non-operatively treated traumatic arthrotomy.
3. To determine the incidence of developing a septic arthritis in patients with operative
treatment of a traumatic arthrotomy.
4. To determine the need for additional surgery (ex: foreign body removal) in patients with
a non-operatively treated traumatic arthrotomy.
5. To provide a description of traumatic arthrotomies successfully treated non-operatively.
Study Design Prospective Multi-center Observational Cohort
Inclusion Criteria:
- Any patient 18 and older with a traumatic arthrotomy (of any major joint) confirmed by
saline load test
- Direct visualization of a capsular rent or intra-articular contents, or air in the
joint on CT or radiographs.
a. Major Joints Include: i. Knee ii. Elbow iii. Wrist iv. Shoulder v. Hip vi. Ankle
Exclusion Criteria:
- Patients who will have severe problems with maintaining follow-up
We found this trial at
4
sites
Lexington, Kentucky
859) 257-9000
Principal Investigator: Paul E Matuszewski, MD
Phone: 859-218-3138
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
Click here to add this to my saved trials
Charlotte, North Carolina 28204
Principal Investigator: Joseph Hsu, MD
Phone: 704-355-6969
Click here to add this to my saved trials
Greenville, South Carolina 29615
Principal Investigator: Kyle Jeray, MD
Phone: 864-455-1303
Click here to add this to my saved trials
910 Madison Avenue
Memphis, Texas 38163
Memphis, Texas 38163
Principal Investigator: John C Weinlein, MD
Phone: 901-545-7398
Click here to add this to my saved trials