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A Comparison of Arthrocentesis, Arthroscopy and Arthroplasty in the Treatment of Temporomandibular Joint Dysfunction (TMJ)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
ClinicalTrials.gov Identifier:
NCT00636727
First received: February 15, 2008
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Temporomandibular Joint Dysfunction
Procedure: arthrocentesis
Procedure: arthroscopy
Procedure: arthroplasty

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Arthrocentesis, Arthroscopy and Arthroplasty in the Treatment of Temporomandibular Joint Dysfunction

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Reduction in pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2007
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
arthrocentesis
Procedure: arthrocentesis
Irrigate the TMJ with lactated ringers
Active Comparator: 2
arthroscopy
Procedure: arthroscopy
The TMJ will be inspected with an arthroscope and the joint irrigated with lactated ringers
Active Comparator: 3
arthroplasty
Procedure: arthroplasty
The disc will be surgically repositioned with open surgery

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who require a surgical intervention

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636727

Locations
United States, Georgia
Emory Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Gary f Bouloux, MD, DDS Emory University
  More Information

No publications provided

Responsible Party: Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Doctor, Emory University
ClinicalTrials.gov Identifier: NCT00636727     History of Changes
Other Study ID Numbers: IRB00000450
Study First Received: February 15, 2008
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
arthrocentesis
arthroscopy
arthroplasty

Additional relevant MeSH terms:
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Jaw Diseases
Mandibular Diseases
Muscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 20, 2014