NCT00762944已完成不适用
Survivibility of the Total Temporomandibular Joint Replacement System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 4
- 主要终点
- Time to Revision
研究概览
简要总结
Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data [PMA P020016]
详细描述
An additional three-year follow-up data will be collected on subjects previously enrolled in the PMA study, who had not completed follow-up prior to the PMA approval [PMA P020016].
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 requiring total joint reconstruction due to:
- •Arthritis (osteoarthritis, rheumatoid, traumatic) malignancy Ankylosis functional deformity Avascular necrosis revisions Benign neoplasms fracture Multiple operated joints
- •Patients who are skeletally mature.
- •Patients must have at least one of the following criteria for surgical TMJ treatment.
- •Presence of considerable pain and/or limited function in the joint area.
- •Clinical and imaging evidence consistent with anatomic joint pathology
- •Previous failure of non-surgical treatment/therapy or a failed implant.
- •High probability of patient improvement by surgical treatment.
- •Patients must be able to return for follow-up examinations.
- •Patients without serious compromising general medical conditions.
排除标准
- •Patients with active infection.
- •Patient conditions where there is insufficient quantity or quality of bone to support the device
- •Patients with perforations in the mandibular fossa and/or bony deficiencies in the articular eminence compromising support for the artificial fossa component.
- •Patients with mandibular and/or zygomatic arch screw holes compromising component fixation
- •Patients requiring partial joint reconstruction or other TMJ procedures not listed as an indication.
- •Patients who are NOT skeletally mature.
- •Patients who are incapable or unwilling to follow postoperative care instructions.
- •Patients who are unable to return for follow-up examinations.
- •Patients with severe hyper-functional habits
- •Patients on chronic steroid therapy.
结局指标
主要结局
Time to Revision
时间窗: 3 years
Time from surgical alloplastic reconstruction of the TMJ to revision surgery (Re-operation or removal)
次要结局
- jaw pain intensity (VAS score)(1 year, 1.5 years)
- Interference with eating(1 year, 1.5 years)
- Maximun Incisal Opening(1 year, 1.5 years)
- Patient Satisfaction(6 months, 1 year, 1.5 years, and 3 years)
研究者
研究点 (4)
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