Temporomandibular Joint Dysfunction Clinical Trial
Official title:
A Comparison of Arthrocentesis, Arthroscopy and Arthroplasty in the Treatment of Temporomandibular Joint Dysfunction
Many patients suffer from a disorder known as temporomandibular joint dysfunction. This
disorder has jaw joint pain and limited function as key elements. Many treatments have been
advocated over the last 40 years, many of them deleterious. Currently treatment can be
divided into four categories. The first is non-surgical and involves vocal rest, soft diet,
heat, anti-inflammatory medications, muscle relaxants, splint therapy and physical therapy.
All patients benefit to some degree utilizing one or more non-surgical approaches.
Controversy exists with respect to which of the next three categories of treatment is ideal.
Some advocate arthrocentesis which involves placing two small needles into the joint to
allow irrigation and instillation of anti-inflammatory medication. This is a minimally
invasive procedure performed under local anesthetic alone or with intravenous sedation.
Others advocate arthroscopy which involves placing an arthroscope (a thin tube about 2mm in
diameter with optical elements allowing one to see inside a joint) to visualize the inside
of a joint. Furthermore the joint can be irrigated, scar bands removed, ligaments stretched
and medication instilled. This is performed under a general anesthesia. Depending on the
study, success for both arthrocentesis and arthroscopy has been reported to be about 80-90%.
Still there are others who recommend arthroplasty which is an open joint surgical procedure
that allows the surgeon to enter the joint and directly repair or remove the damaged
cartilage disc within the joint. This is performed under a general anesthesia. Similar
success rates of 80-94% have been reported. It is clear that some patients only require
arthrocentesis, others arthroscopy and others arthroplasty. We currently do not have any
real mechanism of predicting which patients will benefit the most from which procedure.
This study will enable patients undergoing each procedure to be followed closely with the
hope that we can determine objective factors that will allow us to stratify patients into
one of the three surgical options: arthrocentesis, arthroscopy or arthroplasty. Our current
approach is empiric and typically proceeds from arthrocentesis to arthroscopy to
arthroplasty. All patients in this study will be offered the opportunity to have
arthrocentesis performed. It is anticipated that a minority will achieve long-term benefit
in terms of pain and function. We hope to be able to identify those factors which will
predict which patients will benefit so that future patients selected to have arthrocentesis
will have much higher success rates. Patients who fail to improve with arthrocentesis or who
initially decline that procedure will be offered the opportunity to undergo arthroscopy. It
is anticipated that a majority of patients will achieve long-term benefit in terms of pain
and function. Again it is hoped that we can identify those factors which will predict which
patients will benefit so that future patients selected to have arthroscopy will have even
higher success rates. Patients who fail to improve with arthroscopy or who initially decline
both arthrocentesis and arthroscopy will be offered the opportunity to undergo arthroplasty
provided that clinical and radiographic evidence exists to support the presence of either a
diseased or displaced cartilage disc.
Our ability to adequately treat patients with temporomandibular joint dysfunction will be
significantly improved if we can better stratify patients and follow an evidence based
surgical algorithm that provides the greatest opportunity for success while reducing
potential complications. Each of these surgical procedures is the standard of care
throughout the USA but unfortunately the choice of which procedure to perform is often
empiric and guided more by training and surgical experience.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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