NCT02203448已完成不适用
A Multi-centre, Prospective, Single-arm Post Market Clinical Follow up Study (PMCF) of the FACET WEDGE Spinal System to Assess Outcomes in Subjects With Chronic Low Back Pain Due to Degenerative Disc Disease (DDD), Facet Joint Disease and/or Pseudo Arthrosis Post Anterior Instrumentation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Synthes GmbH
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- reoperation rate at the index level(s)
研究概览
简要总结
A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint disease and/or pseudo arthrosis post anterior instrumentation. The objective of this study is to assess outcomes following implantation of the FACET WEDGE spinal system when used to provide fixation of lumbar motion segments.
The primary objective of this study is to determine the rate of re-operations at the index level(s).
The secondary objectives of this study are to confirm the safety and performance of the device and to collect patient reported outcome data.
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
- •Subjects diagnosed with at least one of the following:
- •Degenerative Disc Disease (DDD);
- •Degenerative facet joint disease (isolated facet based symptomatic back pain);
- •Pseudoarthrosis post anterior instrumentation;
- •Subjects who are a fusion candidate for single or multiple levels fusion between L1-S1;
- •Subjects, who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
排除标准
- •Preoperative exclusion criteria:
- •Segmental instability of the index level in case of planned stand-alone FACET WEDGE usage;
- •Unilateral application , except in combination with pediclescrew fixation on the contralateral side;
- •Compromised facets due to decompression techniques;
- •Spondylolisthesis;
- •Fracture or other instabilities of the posterior elements;
- •Acute or chronic systemic or localized spinal infections;
- •Nursing mothers or women who are pregnant or plan to become pregnant during the time of the study;
- •Subjects aged below 18 years;
- •Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation;
- •Intraoperative exclusion criteria:
- •Intraoperative decision to use implants other than the device under investigation.
结局指标
主要结局
reoperation rate at the index level(s)
时间窗: at two years
次要结局
- the radiographic range of motion (ROM) at the index levels(Pre-treatment, 6 months, 12 months, 24 months)
- patient (back and leg) pain reported on a Numeric Rating Scale (NRS)(pre-treatment, prior to D/C, 6 weeks, 6 months, 12 months, 24 months.)
- functional success based on results from the Oswestry Disability Index (ODI)(Pre-treatment, 6 weeks, 6 months, 12 months, 24 months)
- Adverse events(Throughout the study)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in AsiaLens OpacitiesCataractAstigmatismNCT04778501Beaver-Visitec International, Inc.45
已完成
不适用
PMCF Study on Monofocal Toric IOL (PODEYE TORIC)Lens OpacitiesCataractAstigmatismNCT04744467Beaver-Visitec International, Inc.12
已完成
不适用
PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Europe (PHY2104)CataractLens OpacitiesAstigmatismNCT04987216Beaver-Visitec International, Inc.28
终止
不适用
directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential TremorEssential TremorNCT05795218Aleva Neurotherapeutics SA21
已完成
不适用
PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in SpainLens OpacitiesCataractAstigmatismNCT04866719Beaver-Visitec International, Inc.76