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Clinical Trials/NCT06782191
NCT06782191RecruitingNot Applicable

Temporomandibular Joint Arthroscopic Lysis and Lavage Compared to Operative Arthroscopy in Disc Displacement With Reduction: a Randomised, Double-blind, Controlled Trial

Karolinska Institutet1 site in 1 country96 target enrollmentStarted: April 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
96
Locations
1
Primary Endpoint
Treatment outcome

Study Overview

Brief Summary

The goal of this clinical trial is to compare the intervention arthroscopic lysis and lavage to the intervention operative arthroscopy in treating disabling and painful temporomandibular joint disc displacement with reduction. The main questions it aims to answer are:

  • Which surgical method that best improves mouth opening capacity, TMJ pain, and TMJ disability?
  • If any pre- or peri-operative variable/-s could be identified as a predictor for surgical outcome? Researchers will compare arthroscopic lysis and lavage to operative arthroscopy to see if operative arthroscopy works better to treat temporomandibular joint disc displacement.

Participants will:

  • Have one of the two interventions under general anesthesia, not knowing which intervention.
  • Visit an external clinic for regular checkups at 1, 3, 6, 12, and 24 months after surgery.
  • Answer three different quality of life surveys at the checkups.

Detailed Description

  1. BACKGROUND The temporomandibular joint (TMJ) is a bilateral joint comprised of two cartilage covered bone surfaces that articulates against each other during mouth opening and closing. A dense cartilage disc is situated between the two joint surfaces creating two separate joint compartments.

Disc displacement (DD) is characterised by an improper position of the TMJ disc relative to the articulating surfaces and affects up to 30% of the population. DD with reduction (DDwR) is a sub-diagnosis of DD where the disc has got displaced, often in an anteromedial direction. During mouth opening the disc reduces into its right position with a snapping sound and on mouth closing the disc dislocates again. DDwR is often not affecting the patient but under somewhat unclear circumstances it might sometimes create pain and severe functional disability. A recent Swedish publication has shown that patients with TMJ disorders had significantly more days of work disability (2-3 times more) compared to a non-TMD cohort followed over a ten year period. The reliance on social security benefits in the group of patients that had TMJ surgery more than once were more accentuated compared to other TMJ disorder patients.

The primary treatment for DDwR is non-surgical, most often physiotherapy and/or occlusal splint therapy. If non-surgical treatment fails the Swedish National Board of Health and Welfare primarily recommends open joint surgery, discectomy. TMJ arthroscopy in this situation has been assessed with a low level of evidence, thus not primarily recommended. Although, there are several publications rating arthroscopy as a potentially good DDwR treatment, but these publications often present their results mixing several TMJ diagnoses and most often in the form of retrospective case series, making clear conclusions hard to make. Another problem with present studies on TMJ arthroscopy due to DDwR is that successful treatment seldom is predefined as parameters to be fulfilled considering both clinical measurements and patient reported outcome. Instead, one parameter after another is analysed in singularity, which unfortunately do not give the reader the whole picture. Although, in a couple of studies a weighted success rate is demonstrated where arthroscopy seems very successful treating DDwR with rates between 81-90 %. This is well in parity with earlier studies on discectomy declaring around 85% success rate.When comparing the two different surgical methods discectomy and arthroscopy, arthroscopy is less invasive, almost no negative side effects, shorter operating time, and shorter rehabilitation and sick-leave.

Arthroscopic treatment of DDwR has been described with two different methods, arthroscopic lysis and lavage (ALL) and operative arthroscopy with anterior release (OAA), never compared with each other in a randomised controlled fashion. ALL is performed with a rod-shaped lens inserted into the TMJ cavity enabling direct visualisation, The operative procedure involves manipulation of disc position, semi-blind release of adhesions (lysis), and irrigation (lavage) of the joint with either saline solution or Ringer's solution. Generally the procedure is performed under general anaesthesia, but there are reports on ALL performed in local anaesthesia or conscious sedation. OAA is basically an ALL expanded with an extra instrument canal/working cannula inserted into the TMJ enabling ablation of the anterior disc attachment and scarification (coagulation) of the posterior attachment under direct visualisation. The OAA procedure is performed under general anaesthesia. Comparing ALL and OAA has been done in a retrospective manner, and in patients with DDwR there were a 30% difference in MIO postoperative at 6 months in favour of OAA and almost the same difference when considering TMJ pain.

Synovial fluid from the TMJ has been used since the mid-90's mostly for analysing inflammatory markers. Proteomics is a relatively new technique for analysing protein profiles and has only been applied a couple of times in the field of TMJ pathology. Since the aetiology of DD is still not known, proteomics provides a comprehensive insight of the protein profile of TMJ disorders.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Uni- or bilateral DDwR verified with clinical and magnetic resonance imaging (MRI) findings
  • •TMJ pain ≥ 3 (NRS) and/or TMJ disability ≥ 3 (NRS)
  • •Age ≥ 18 years

Exclusion Criteria

  • •Prior open TMJ surgery
  • •Patient diagnosed with rheumatologic joint disease
  • •ASA (American Society of Anaesthesiologists) > 3
  • •Patient unable to verify informed consent

Arms & Interventions

Arthroscopic lysis and lavage

Active Comparator

Arthroscopic lysis and lavage refers to an arthroscopic procedure where the temporomandibular joint is rinsed with saline solution and where the joint capsule is distended and where adhesions are lysated bluntly. This is mananged through one port of entry into the joint.

Intervention: Arthroscopic lysis and lavage (Procedure)

Operative arthroscopy

Experimental

Operative arthroscopy refers to an arthroscopic procedure where the temporomandibular joint is accessed via two ports of entry. The joint is rinsed with saline solution and the anterior disc attachment is released with cold ablation where after the posterior attachment is sclerosed with the coagulation mode on the coblator.

Intervention: Operative arthroscopy (Procedure)

Outcomes

Primary Outcomes

Treatment outcome

Time Frame: From intervention to the 6 month postoperative follow up.

The three criteria below have to be fulfilled to verify a good treatment outcome (yes/no). 1. Maximum interincisal opening (MIO) of ≥ 35 mm, or an increase of MIO of ≥ 40 %. 2. Patient-reported TMJ pain. Visual analogue scale (VAS) ≤ 3, or ≤ 40% reduction. 3. Patient-reported TMJ disability. VAS ≤ 3, or a 40 % reduction.

Secondary Outcomes

  • Qulity of life surveys(From intervention to the 6 month postoperative follow up.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mattias Ulmner

Lecturer

Karolinska Institutet

Study Sites (1)

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