A Prospective Case Series to Evaluate Handling and Feasibility of DensiProbe Spine Assessing Vertebral Bone Strength in Patients Undergoing Transpedicular Fixation of the Spine - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Intra- and post-operative adverse events
研究概览
简要总结
A new mechanical device was developed in order to provide the surgeon with intraoperative information about the mechanical strength of the cancellous bone within the vertebral body. DensiProbe Spine is intended to be used in patients undergoing transpedicular stabilization of the thoracolumbar spine. The objective of the DensiProbe Spine pilot study is to investigate the handling and feasibility of the DensiProbe Spine measurement device.
详细描述
Osteoporotic fragility fractures often occur in the spine. A common surgical technique is the transpedicular fixation using pedicle screws. A major complication of this treatment is a cut-out or back-out of the screw due to insufficient anchorage of the implant in the vertebral body.
A new mechanical device was developed in order to provide the surgeon with intraoperative information about the mechanical strength of the cancellous bone. In cases of low bone quality, the treatment can be adapted to the patient's condition, for example by augmentation of the screw anchorage using bone cement. However, this treatment involves a risk of cement leakage and subsequent pulmonary embolism or nerve damage. Furthermore, cement augmentation is time-consuming. Therefore, there is a need for a diagnostic device that can intraoperatively support the surgeon's decision on the appropriate treatment.
DensiProbe Spine was developed accordingly to the clinically approved DensiProbe Hip, which was designed for the same diagnostic reasons in patients with hip fractures undergoing fracture fixation with the dynamic hip screw (DHS). However, the application of bone strength measurements in the spine is in so far different to the hip as the anatomical dimensions in the spine are much smaller and lower values of bone mineral density (BMD) and bone strength are expected.
The objective of this pilot study is to investigate the handling and feasibility of the newly developed DensiProbe Spine measurement device. In case of a positive result of the pilot study, a multicenter cohort study will be performed in order to clinically validate the DensiProbe Spine device by assessing the correlation between DensiProbe Spine measurements and the amounts of pedicle screw migration in patients undergoing transpedicular fixation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Indication for transpedicular fixation of the thoracolumbar spine
- •Ability to understand and read local language at an elementary level
- •Signed informed consent by patient or legal guardian to participate in the study according to the protocol
排除标准
- •Patients who are legally incompetent
- •Scoliosis (Cobb angle on AP radiograph > 10°)
- •Benign or malign vertebral bone tumour
- •Active malignancy
- •Infection diseases, eg. hepatitis, human immunodeficiency virus (HIV)
- •Pre-drilling with power-drill
- •Life-threatening condition
- •Drug or alcohol abuse
- •Participation in any other medical device or drug study that could influence the results of the present study
结局指标
主要结局
Intra- and post-operative adverse events
时间窗: Up to 2 months postsurgery
All intra- and postoperative adverse events will be assessed and analyzed regarding their relationship to the study device
Surgeon's compliance- and handling-oriented questionnaire
时间窗: Baseline
The general satisfaction of the surgeon with DensiProbe Spine as well as specific problems that are likely to occur during the measurement with DensiProbe Spine will be assessed
次要结局
- Bone mineral density(Baseline)
- QCT analysis of bone biopsies(Baseline)
- Pedicle screw migration(2 months postsurgery)
- Application of bone cement(Baseline)