Diagnostic arthroscopic (lysis and lavage) reduces clinical symptoms more rapidly and efficaciously than arthrocentesis.
ID
Bron
Verkorte titel
Aandoening
Arthralgia, internal derangement and degenerative joint disease (i.e. osteoarthritis) of the temporomandibular joint
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Pain perceived by the patient during mandibular movement or function using the Visual Analogue Scale (VAS; ranging 0-100mm).
Achtergrond van het onderzoek
Internal derangement (ID) and degenerative joint disease (DJD) of the temporomandibular joint (TMJ) are the most common causes of arthralgia of the TMJ. When these disorders are symptomatic, elevated pro-inflammatory cytokines and degradation products are often present in the synovial fluid of the joint. The lavage of the joint with arthrocentesis as initial treatment may wash these harmful products away and is shown to be an (cost-)efficient way in reducing clinical symptoms of DJD and ID.
The more advanced procedure diagnostic arthroscopy/ single portal arthroscopic lysis and lavage under localized anesthesia also enables the lavage of the joint, but additionally allows lysis and localized injections with corticosteroids. Currently, diagnostic arthroscopy is only performed when arthrocentesis is proven to be insufficient in reducing clinical symptoms. Indicating diagnostic arthroscopy as first-line (therefore replacing arthrocentesis) treatment for TMJ-arthralgia may prevent further degeneration of the joint and reduce clinical symptoms more efficiently than arthrocentesis.
The aim of the study is therefore to evaluate the (cost-)efficiency of diagnostic arthroscopy in reducing clinical symptoms compared to arthrocentesis under local
anesthesia as initial treatment in patients with arthralgia (with or without reduced mobility) of the TMJ.
The study design is a single-center single-blind randomized controlled trial, conducted in the University Medical Center Groningen (UMCG). An estimated 140 subjects will be randomized in two arms (50:50 ratio).
Doel van het onderzoek
Diagnostic arthroscopic (lysis and lavage) reduces clinical symptoms more rapidly and efficaciously than arthrocentesis.
Onderzoeksopzet
3 months, 6 months and 12 months.
Onderzoeksproduct en/of interventie
Investigational intervention is diagnostic arthroscopic (lysis and lavage);
Control intervention is arthrocentesis
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients aged > 18 years
- Arthralgia of the TMJ, proven with a diagnostic intra-articular injection with Ultracain DS Forte (articaine 4% + 1:100.000 adrenalin; Aventis Pharma, Hoevelaken, The Netherlands).
- TMJ pain still present after two weeks of NSAIDs (i.e. diclofenac 3 times daily 50mg)
- Symptoms presenting unilaterally or bilaterally with a maximal Visual Analog Scale (VAS)-score < 30 mm during movement or function of the contralateral joint, after anesthetizing the to be treated joint (thus avoiding the contralateral joint to be the cause of a limited mouth opening).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Systemic rheumatic disease (such as rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, Sjögren syndromes, psoriatic arthritis)
- Connective tissue disease (such as Marfan syndrome, Ehlers-Danlos syndrome, Osteogenesis Imperfecta)
- Bony ankylosis of the TMJ
- Congenital or acquired dentofacial deformity
- History of jaw trauma that resulted in jaw or joint pain, bony changes or mandibular growth restriction
- Prior arthrocentesis, (diagnostic) arthroscopy or open-TMJ surgery
- Psychiatric disorder (as diagnosed by a physician)
- Unwillingness to receive one of the study treatments
- Pregnancy at time of treatment
- Concurrent use of steroids, sedatives, muscle relaxants or anti-inflammatory drugs other than the previously prescribed NSAIDs
- Incompetence to speak the Dutch or English language
- Medical comorbidities such as coagulation disorders, diabetes mellitus type I or II, kidney failure, heart failure, cardiac ischemia, hypertension and history of HIV.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9701 |
| Ander register | METC UMCG : METc 2021/275 |