NCT01895426已完成不适用
Clinical Follow-up of the ArcadiusXP L Stand Alone Intervertebral Body Fusion Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- ODI (2y) - ODI(preop)
研究概览
简要总结
The purpose of this study is to collect clinical and radiological mid-term (2 years) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 32 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all indications as given by the instructions for use
- •Patients with persisting lumbosacral and pseudo-radicular pain scheduled for monosegmental lumbar interbody fusion from L4 to S1
- •Age 18 - 60
- •at least 6 months of unsuccessful treatment including conservative measures
- •Non-sequestrated and subligamentous prolapse
排除标准
- •all contraindications, which are listed in the instructions for use.
- •existing pregnancy, planned or occurring during study period
- •patients with a higher degree of segmental degeneration in other than the segment to be operated
- •body- mass-index (BMI) > 30
- •Systemic or local infection
- •Increased risk of osteoporosis according to assessment by the SCORE evaluation
- •Bone metabolism disorders
- •Chemotherapy or radiotherapy (ongoing or planned)
- •Participation in another clinical trial
- •Scheduled for spinal litigation
- •Other serious conditions that hinder the participation in the study
- •Nanogel® filling of the cage, prior to implantation was not done
结局指标
主要结局
ODI (2y) - ODI(preop)
时间窗: 2 years
Difference between Oswestry Disability Index (ODI) at 2 years and preoperative ODI
次要结局
- Concomitant pain medication(2 years)
- Overall success(2 years)
- Pain (back and leg)(2 years)
- Adverse events(2 years)
- Fusion/arthrodesis status, and further radiological documentation of operated and adjacent levels(2 years)
- Patient satisfaction(2 years)
研究者
研究点 (2)
Loading locations...
相似试验
撤回
不适用
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion DeviceChronic Low-back PainSpondylolysis LumbarPostdiscectomy SyndromePosttraumatic InstabilityDegenerative Disc DiseaseNCT05944081Aesculap AG60
撤回
不适用
Evaluation of Clinical and Radiographic Outcomes of Surgical Treatment for Rotator Cuff Injury in Patients Over 70Cuff Rotator SyndromeNCT05082844Istituto Ortopedico Rizzoli
已完成
不适用
Observational Retrospective Study on the Clinical and Radiographic Outcomes of the Aseptic Pseudarthrosis Treatment of the Upper LimbPseudarthrosisNCT04200872Istituto Ortopedico Rizzoli90
已完成
不适用
A Clinical Investigation of ArComXL® Polyethylene in Total Hip ReplacementRheumatoid ArthritisOsteoarthritisAvascular NecrosisNCT00698152Zimmer Biomet149
Unknown
4 期
This is a 2 Year Follow up Clinical and Radiographic Analysis of a Novel All Polyethelene Glenoid Component in Standard Total Shoulder Arthroplasty.The Primary Disease Process Being Studied is Shoulder OA and the Effect of an All Polyethelene Glenoid Component on Shoulder ArthroplastyNCT01313741Knoxville Orthopedic Clinic200