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Operative and Non-operative Treatment of Traumatic Arthrotomies

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ClinicalTrials.gov Identifier: NCT02841644
Recruitment Status : Recruiting
First Posted : July 22, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Joseph Hsu, Atrium Health

Tracking Information
First Submitted Date June 27, 2016
First Posted Date July 22, 2016
Last Update Posted Date November 14, 2018
Study Start Date April 2015
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 19, 2016)
Cost of treatments [ Time Frame: 12 months ]
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02841644 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 19, 2016)
  • Superficial wound infection [ Time Frame: 12 months ]
    To determine the incidence of developing a septic arthritis and other infections in patients treated operatively or non-operatively treated traumatic arthrotomy.
  • Pain [ Time Frame: 12 months ]
    To determine pain levels in patients treated operatively versus non-operatively traumatic arthrotomy.
  • Return to work or previous level of activity [ Time Frame: 12 months ]
    To determine return to work or previous level activity in patients treated operatively versus non-operatively traumatic arthrotomy.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Operative and Non-operative Treatment of Traumatic Arthrotomies
Official Title Operative and Non-operative Treatment of Traumatic Arthrotomies: A Prospective Observational Study
Brief Summary 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.
Detailed Description

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

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Any patient 18 years and older with a traumatic arthrotomy
Condition Traumatic Arthrotomy
Intervention Not Provided
Study Groups/Cohorts Traumatic Arthrotomy
Patient diagnosed with traumatic arthrotomy.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 19, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christine Churchilll, MA 704-355-6947 Christine.Churchill@carolinashealthcare.org
Contact: Rachel Seymour, PhD 704-355-6969 Rachel.Seymour@carolinashealthcare.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02841644
Other Study ID Numbers 04-15-05E
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: undecided
Responsible Party Joseph Hsu, Atrium Health
Study Sponsor Atrium Health
Collaborators Not Provided
Investigators
Principal Investigator: Joseph Hsu, MD Atrium Health
PRS Account Atrium Health
Verification Date November 2018