Retrospective Study on the Use of a Human Bone Graft (Shark Screw®) in Hand- and Foot Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Osseous consolidation of the transplant
研究概览
简要总结
This observational study aims to determine the efficacy and safety of the Shark Screw® transplant for osteotomy and arthrodesis in hand and foot surgery.
详细描述
The Shark Screw® transplant (surgebright GmbH) is a human cortical bone allograft for osteosynthesis and can replace metal or bioabsorbable devices in various procedures. In total, the clinical records from 32 patients who had undergone surgical procedure at the hand or foot between October 2016 and January 2018 with the use of a Shark Screw® transplant for joint arthrodesis or for the stabilization of osteotomies serve as data sources for this study. The aim of this study is to evaluate the efficacy and safety of the Shark Screw® transplant in hand and foot surgery by analyzing the recovery, wound and bone healing process.
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
- 否
入选标准
- •Application of the human bone graft Shark Screw® in a Hand- or Foot surgical procedure between October 2016 and January 2018
- •Data from at least 1 follow-up examination after surgery around the 6th post-operative week or other information about the health status of the patient in the first 6 post-operative weeks
排除标准
- •not enough data for an objective analysis
结局指标
主要结局
Osseous consolidation of the transplant
时间窗: 1 year
Absence of radiolucent lines around the transplant in the x-ray
Evaluation pre- and postoperative pain (VAS)
时间窗: 1 year
The visual analogue scale (VAS) is a vertical line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extremes (0mm = no pain - 100mm = worst imaginable pain). A higher score indicates more pain.
次要结局
- Incidence of postoperative complication and soft tissue irritation(1 year)
- Incidence of surgical revision(1 year)
- Duration of post-operative analgesic medication(1 year)
- Incidence of cracking or loosening of the screw(1 year)
- Cellular contact to the recipient bone(1 year)
- Resorptive processes in the recipient bone(1 year)
- Patient satisfaction(1 year)
- Incidence of postoperative pseudarthrosis(1 year)