A Single-arm, Prospective Study of Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Time to plan/perform case
研究概览
简要总结
Compare sizing determined in pre-operative planning of reverse shoulder arthroplasty to operative implant size selected.
详细描述
The Blueprint planning software automatically creates a virtual implantation environment for the surgeon to use. The use of 3D measurements is independent of patient positioning, which results in more accurate measurements of the glenoid version and inclination measurements in shoulder replacement surgery.
Pre-operative planning with Blueprint can accurately predict intraoperative implant selection within one size. Also, pre-operative planning leads to case efficiency and improved functional outcomes at 6 months post-operative compared to Baseline.
The objective of this study is to characterize implant size accuracy, planning time, functional outcomes, and procedural time (i.e., surgical time) using Blueprint planning software in subjects who are candidates for reverse shoulder arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Skeletally mature, and age ≥ 18 years.
- •In the opinion of the treating surgeon, must already be a qualified candidate for reverse shoulder arthroplasty without the use of glenoid bone grafts.
- •Be likely to return for regular follow-ups until the end of the study period.
- •Be willing and able to provide Informed Consent for study participation.
排除标准
- •Previous bony surgery on the operative shoulder.
- •Shoulder pain due to acute trauma.
- •Clinical, laboratory and/or radiological evidence of shoulder pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
- •Any active malignancy, infectious process, or documented chronic autoimmune disease.
- •Any other concurrent medical disease or treatment that might impair normal healing process.
- •Recent history (within past 6 months) of any chemical or alcohol dependence.
- •Currently a prisoner.
- •Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
- •Pregnant or planning to become pregnant within study duration.
结局指标
主要结局
Time to plan/perform case
时间窗: Perioperative
Time required for surgeon to plan and perform the case using the Bluerpint software
Accuracy of sizing
时间窗: Perioperative
Blueprint planned implant size compared to actual implant size
Range of motion
时间窗: 6 months
Range of motion of the operative shoulder
次要结局
- Simple Shoulder Test (SST) Questionnaire(6 months)
- American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)(6 months)
- Patient Satisfaction(6 months)