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Traumatic ArthrotomyNCT02841644

Operative and Non-operative Treatment of Traumatic Arthrotomies

An observational study of Traumatic Arthrotomy, run by Wake Forest University Health Sciences at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Arthrotomy
What is being tested?
Operatively treated traumatic arthrotomy and Non-operatively treated traumatic arthrotomy
Type of treatment
Surgery or procedure
How many people
180 participants
Where
4 sitesUnited States
Study dates
Apr 2015to Apr 2020
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Any patient 18 years and older with a traumatic arthrotomy

Who may be able to join

  • 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.
  • Major Joints Include: i. Knee ii. Elbow iii. Wrist iv. Shoulder v. Hip vi. Ankle

Who cannot join

  • Patients who will have severe problems with maintaining follow-up

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Carolinas Medical Center- Main

    Charlotte, North Carolina, 28204

  • Greenville Health System

    Greenville, South Carolina, 29605

  • University of Kentucky

    Lexington, Kentucky, 40506

  • The University of Tennessee Health Science Center

    Memphis, Texas, 38163

Other trials in United States

About this study

Official title: 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.

Read the 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

Being tested
Operatively treated traumatic arthrotomy, Non-operatively treated traumatic arthrotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Operatively treated traumatic arthrotomyProcedure or surgery

    operatively treated traumatic arthrotomy.

  • Non-operatively treated traumatic arthrotomyOther

    non-operatively treated traumatic arthrotomy.

Study groups in NCT02841644
Study groupRoleWhat they receive
Traumatic Arthrotomy- Treated NonoperativelyPatient diagnosed with traumatic arthrotomy treated nonoperatively.
Receives: Other: Non-operatively treated traumatic arthrotomy
Traumatic Arthrotomy- Treated OperativelyPatient diagnosed with traumatic arthrotomy treated operatively.
Receives: Procedure: Operatively treated traumatic arthrotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cost of Treatments

    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. To estimate cost associated with TAs, total charge data was acquired for all patients treated at the lead site.

    Measured: 12 months

  2. Complications

    Complications were defined as septic arthritis, return to the OR, rehospitalization, and osteomyelitis of the injured joint.

    Measured: 12 months

Secondary outcomes (1)
  1. Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method

    The veteran rand 12-tem health survey is used to determine change in health related quality of life to estimate disease burden. It is summarized into two scores, a physical component scores (PCS) (range 0-100) and mental component scores (range- 0-100). Higher score indicate better outcomes.

    Measured: baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2016 (estimated)
  2. Study startApr 2015
  3. Primary completionApr 2019
  4. Study completionApr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02841644
Sponsor's protocol ID
04-15-05E
Status last verified
Jan 2022
First submitted
27 Jun 2016
Last updated
14 Jul 2022
Data monitoring committee
No
Individual data sharing
Undecided: undecided

Publications

  • HAMPTON OP Jr. The management of penetrating wounds and suppurative arthritis of the knee joint in the Mediterranean Theater of Operations. J Bone Joint Surg Am. 1946 Oct;28(4):659-80. No abstract available.

    PubMed 21003176
  • Levy AS, Lefkoe TP, Whitelaw GP, Kohler S. Management of penetrating pneumatic nailgun injuries of the knee. J Orthop Trauma. 1991;5(1):66-70. doi: 10.1097/00005131-199103000-00012.

    PubMed 2023046
  • Patzakis MJ, Dorr LD, Ivler D, Moore TM, Harvey JP Jr. The early management of open joint injuries. A prospective study of one hundred and forty patients. J Bone Joint Surg Am. 1975 Dec;57(8):1065-70.

    PubMed 1201988
  • Marvel JE, Marsh HO. Management of penetrating injuries of the knee. Clin Orthop Relat Res. 1977 Jan-Feb;(122):268-72.

    PubMed 837616
  • Lanier WL. A three-decade perspective on anesthesia safety. Am Surg. 2006 Nov;72(11):985-9; discussion 1021-30, 1133-48. doi: 10.1177/000313480607201101.

    PubMed 17120937
  • Botney R. Improving patient safety in anesthesia: a success story? Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S182-6. doi: 10.1016/j.ijrobp.2007.05.095.

    PubMed 18406924
  • Wolters U, Wolf T, Stutzer H, Schroder T. ASA classification and perioperative variables as predictors of postoperative outcome. Br J Anaesth. 1996 Aug;77(2):217-22. doi: 10.1093/bja/77.2.217.

    PubMed 8881629
  • Chander S, Coakley G. What's New in the Management of Bacterial Septic Arthritis? Curr Infect Dis Rep. 2011 Oct;13(5):478-84. doi: 10.1007/s11908-011-0201-0.

    PubMed 21785928
  • Tornetta P 3rd, Boes MT, Schepsis AA, Foster TE, Bhandari M, Garcia E. How effective is a saline arthrogram for wounds around the knee? Clin Orthop Relat Res. 2008 Feb;466(2):432-5. doi: 10.1007/s11999-007-0006-5. Epub 2008 Jan 10.

    PubMed 18196428
  • Nord RM, Quach T, Walsh M, Pereira D, Tejwani NC. Detection of traumatic arthrotomy of the knee using the saline solution load test. J Bone Joint Surg Am. 2009 Jan;91(1):66-70. doi: 10.2106/JBJS.G.01682.

    PubMed 19122080
  • Metzger P, Carney J, Kuhn K, Booher K, Mazurek M. Sensitivity of the saline load test with and without methylene blue dye in the diagnosis of artificial traumatic knee arthrotomies. J Orthop Trauma. 2012 Jun;26(6):347-9. doi: 10.1097/BOT.0b013e3182255167.

    PubMed 22215059
  • McKnight RR, Ruffolo M, Wally MK, Seymour RB, Jeray K, E Matuszewski P, Weinlein J, Hsu JR; Southeast Fracture Consortium. Traumatic Arthrotomies: Do They All Need the Operating Room? J Orthop Trauma. 2021 Nov 1;35(11):612-618. doi: 10.1097/BOT.0000000000002093.

    PubMed 34387570

Questions about this trial

What is this clinical trial studying?

An observational study of Traumatic Arthrotomy, run by Wake Forest University Health Sciences at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost of Treatments (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02841644, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.

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