NCT03991728招募中不适用
International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
AO Innovation Translation Center23 个研究点 分布在 15 个国家目标入组 200 人开始时间: 2019年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 23
- 主要终点
- The registry has no primary but several objectives.
研究概览
简要总结
Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications).
This registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.
详细描述
More in detail this registry has the following objectives:
- To describe clinical indications for TMJ replacement, and treatment patterns (including differences among regions if feasible)
- To describe the clinical evolution and outcomes of patients treated with a TMJ replacement
- To explore the relationship(s) between treatment, outcome(s) and quality of life (QoL).
- To identify predictive factors for favorable outcomes (pain reduction, range of motion (ROM), occlusal status, QoL) in patients treated with TMJ replacement.
- To describe the reasons of patients who refused TMJ replacements
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
- •Age 18 years and or older
- •Patients requiring alloplastic total TMJ replacement
- •Informed consent obtained, i.e.:
- •Ability to understand the content of the patient information/informed consent form (ICF)
- •Willingness and ability to participate in the registry according to the Registry Plan (RP)
- •Signed and dated ethics committee (EC) / Institutional review board (IRB) approved written informed consent
排除标准
- •Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
- •Pregnancy or women planning to conceive within the study period
- •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
研究组 & 干预措施
Alloplastic total TMJ replacement
All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. The registry does not dictate any specific treatment.
结局指标
主要结局
The registry has no primary but several objectives.
时间窗: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
due to the study design, no primary objective has been defined and therefore no primary outcome measure either
次要结局
- Demographics(pre-operative)
- Patient Reported Outcomes - Pain numeric rating scale (NRS)(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months))
- Survival(10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
- Comorbidities(pre-operative)
- Clinical and functional outcomes - Helkimo Clinical dysfunction index(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months))
- Patient Reported Outcomes - Jaw function NRS(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months))
- Patient Reported Outcomes - Diet limitation NRS(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months))
- Patient Reported Outcomes - EuroQoL five dimension (EQ-5D-5L)(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
- Refusal of alloplastic total TMJ replacement surgery(pre-operative)
- Clinical and functional outcomes - Mandibular movements(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months))
- Patient Reported Outcomes - Oral Health Impact Profile (OHIP) - 14(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)
- Anticipated treatment or condition-related adverse events (i.e. complications)(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months))
- Radiological parameters - Fracture of ramus component(pre-operative / 10 days / 12 months / 24 months)
- Radiological parameters - Resorption/ osteolysis of surrounding bone(pre-operative / 10 days / 12 months / 24 months)
- Radiological parameters - Status of bone grafts if used (displaced/ resorbed/ healed)(pre-operative / 10 days / 12 months / 24 months)
- Clinical and functional outcomes - Occlusal status(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months))
- Clinical and functional outcomes - Dentition(from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months))
- Radiological parameters - Displacement of ramus component(pre-operative / 10 days / 12 months / 24 months)
- Radiological parameters - Screw loosening(pre-operative / 10 days / 12 months / 24 months)
- Radiological parameters - Presence of ectopic bone(pre-operative / 10 days / 12 months / 24 months)
研究者
研究点 (23)
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