Intra-articular injection of stromal vascular fraction from adipose tissue in osteoartritis of the temporomandibular joint

Withdrawn

• Conditions: jaw inflammation; Osteoartritis; 10023213

• Registration Number: NL-OMON44586
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Age between 18-60 years;Pain in the TMJ region;Pain still present after two weeks of ibuprofen 600 mg three times daily (exclusion of acute inflammatory pain) ;Pain disappears after intra-articular injection (Ultracain forte, Aventis Pharma, Hoevelaken, The Netherlands) ;Pain still present (VAS during movement more than 20mm) after 3 weeks after an initial arthrocentesis.

Exclusion Criteria

Systemic rheumatic disease ;Bony ankylosis of the TMJ ;Incompetence to speak the Dutch or English language ;Pregnancy ;Concurrent use of anti-inflammatory medication, steroids, muscle relaxants or antidepressants ;Unwillingness to receive one of the study treatments ;Prior open TMJ surgery ;Prior to liposuction;Coagulation disorders;BMI >18 ;BMI >25;Abnormalities in bloodanalysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is VAS pain scale (during movement and at rest) at<br /><br>baseline, and at 3, 12 and 26 weeks. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome variables are maximal mouth opening at baseline, and at 3, 12<br /><br>and 26 weeks. Other outcome variables are based on patient questionnaires MFIQ<br /><br>and OHIP, at baseline, and after 3, 12, 26 weeks; complications during follow<br /><br>up; analysis of synovial cytokines at baseline and at 26 weeks; analysis of<br /><br>nucleated cells and characterization of the SVF in the intervention group. </p><br>