Long-term Follow up of TMJ Surgery and Evaluation of the 6-month Control as a Prognostic Marker.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Treatment success.
研究概览
简要总结
The goal of this clinical trial is to evaluate the long-term outcome of surgical intervention (arthroscopy or discectomy) due to the diagnoses temporomandibular joint disc displacement with or without displacement. The main questions it aims to answer are:
- Does the surgical outcome recorded at the earlier 6-month follow up persist at the long-term follow up approximately 10 years postoperatively?
- How does the radiologically determined degree of joint degeneration change with time in patients that have had joint surgery? Researchers will compare the six-month surgical outcome to the ten-year outcome to see if temporomandibular joint surgery results are stable over time.
Participants with an earlier performed joint surgery will:
- Have a clinical examination approximately ten years postoperatively.
- Have a temporomandibular joint x-ray scan performed (cone-beam computed tomography).
详细描述
- BACKGROUND Disc displacement (DD) of the temporomandibular joint (TMJ) is a common condition, reported to affect up to 20-30% of the population. Fortunately, only a minority of the affected experience pain and restricted mandibular movements, which are common reported signs of DD when symptomatic. Primary treatment for TMJ DD is non-surgical interventions such as orthotic splint, physiotherapy, pharmacological therapy, etc., all showing good outcome. If non-surgical management fails, surgical interventions might be considered. There are several reports on arthrocentesis, arthroscopy, and open joint surgery showing good results when treating TMJ DD. Most surgical reports have a follow-up period between 3-24 months and therefore little is known about the long-term outcome. Studies on arthroscopic treatment of the TMJ with the longest follow-up was found to be between 4.4 to 5 years. All these studies were retrospective. One study reporting on the outcome after arthroscopy was performed with a survey sent to 37 patients 10 year postoperative. The situation is almost the same regarding discectomy, with few clinical reports on long-term follow-up (10 years) of the surgical outcome. A 30-year follow-up survey was made on a Swedish patient material in the 1980´s, showing a good outcome.
Since there is a shortage of clinical studies exploring long-term outcome of arthroscopic and open joint surgery, the aim of this study is to do a clinical investigation of a patient cohort earlier prospectively followed for a period of six months postoperative. The plan is to do follow-ups at approximately 10 and 15 years postoperatively. 2. HYPOTHESIS/RESEARCH QUESTIONS Our hypothesis is that the six-month postoperative outcome is a predictive marker for long-term outcome regarding surgical intervention due to TMJ DD. The outcome will be longitudinally evaluated by maximum mouth opening capacity, patient reported TMJ pain and TMJ disability. This was the original outcome parameters used for this patient cohort earlier investigated. The ethical permit for the earlier studies is (EPN 2014/764-31/2 and 2014/622-31/1) and the patients had their surgery between 2014 and 2017.
The primary research question is whether the long-term outcome of surgery in patients with TMJ DD (DDwR and DDwoR) might be correlated to the six-month outcome.
A secondary question is to investigate the long-term outcome of TMJ surgery due to DD.
Tertiary questions:
- Do any of the registered pre-operative variables serve as prognostic markers when correlated to the long-term outcome?
- is the clinical long- or short-term outcome correlated to the radiological outcome?
- Is the preoperative radiological examination predictive for the surgical outcome in long- or short-term?
- Can naturally occurring deterioration of the TMJ surfaces be distinguished from earlier or present symptoms?
- METHODS 3.1. Study design A prospective longitudinal cohort study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients participating in the studies with ethical approval numbers EPN 2014/764-31/2 and 2014/622-31/
- •Initial diagnosis DDwR or DDwoR.
排除标准
- •Patient unable to verify informed consent.
研究组 & 干预措施
Surgically treated patients due to temporomandibular joint disc displacment
The cohort has already been operated (arthroscopy or discectomy) due to temporomandibular joint disc displacement during the years 2014-2017, then participating in a prospective cohort study mainly focusing on surgical outcome predictors (ethical approval: 2014/622-31/1 and 2014/764-31/2). These patients will now be offered a clinical and radiological examination approximately 10 years postoperative.
干预措施: Arthroscopy & saline irrigation alone (Procedure)
Surgically treated patients due to temporomandibular joint disc displacment
The cohort has already been operated (arthroscopy or discectomy) due to temporomandibular joint disc displacement during the years 2014-2017, then participating in a prospective cohort study mainly focusing on surgical outcome predictors (ethical approval: 2014/622-31/1 and 2014/764-31/2). These patients will now be offered a clinical and radiological examination approximately 10 years postoperative.
干预措施: Discectomy (Procedure)
结局指标
主要结局
Treatment success.
时间窗: From intervention to the 10 year follow up.
Treatment outcome (successful, good, intermediate, deteriorated). This is ordinal data and a compiled judgement will be made after evaluating four different parameters: 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. 4. Patient-reported TMJ psychosocial impact. VAS ≤ 3, or a 40 % reduction. * Successful outcome: criteria 1-4 fulfilled * Good: criteria 1 and one or two of criteria 2-4 fulfilled * Intermediate: no criterias fulfilled * Deteriorated: criterias 1-4 worsened
次要结局
- Joint degeneration(From intervention to the 10 year follow up.)
研究者
Mattias Ulmner
Lecturer
Karolinska Institutet