Post-market Clinical Follow-Up Study to Collect Safety, Performance and Clinical Benefits Data of the JuggerKnot Mini Soft Anchor for Use in the Maxillofacial Treatment of Temporomandibular Joint (TMJ)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
研究概览
简要总结
The objective of this retrospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the JuggerKnot Mini Soft Anchor (implant and instrumentation) when used for soft tissue to bone fixation in the treatment of temporomandibular joint (TMJ) surgery. Safety, performance, and clinical benefits will be evaluated at the following time points: pre op, 6 weeks, 3 months and 1-year follow-up. JuggerKnot Mini has been on the market since November of 2011.
详细描述
The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.
The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Implanted with one or more JuggerKnot Mini Soft Anchor(s) with either a 2-0 or 3-0 suture
- •Must have undergone repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible is required for surgical stabilization of the TMJ articular disc
排除标准
- •Local Infection.
- •Patient conditions including blood supply limitations and insufficient quantity or quality off bone or soft tissue.
- •Patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions or patients who are otherwise unwilling or incapable of doing so.
- •Foreign body sensitivity where material sensitivity is suspected.
- •Off-label use.
- •Patient is a prisoner.
- •Patient is a known alcohol or drug abuser.
结局指标
主要结局
Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
时间窗: Out to a minimum of 1 year
Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events.
次要结局
- Device performance and Clinical Benefits Assessed by a Pain Assessment. and Temporomandibular Joint Function of the Pain Assessment Survey Case Report Form.(Out to a minimum of 1 year)
- Device performance and Clinical Benefits Assessed by a TMJ Function Pain Assessment Survey Case Report Form(Out to a minimum of 1 year)
- Device performance and Clinical Benefits Assessed by a Headache Pain Assessment Survey Case Report Form(Out to a minimum of 1 year)