A Multi-Center Prospective, Observational Patient Registry of the Dynamic Locking Screws in Metaphyseal and Diaphyseal Shaft Fractures of the Humerus, Femur and Tibia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Synthes GmbH
- 试验地点
- 1
- 主要终点
- Radiographic callus formation and location of callus evaluation: Change over time
研究概览
简要总结
The purpose of this multi-center patient registry is to obtain first clinical results and to assess short and mid-term clinical outcome data of patients treated with DLS.
详细描述
This is a multicenter, open-label non-comparative, observational patient registry conducted at 15 to 20 clinical sites.
Patients who have agreed participate and have signed an informed patient consent prior to surgery will be included. Follow-up visits will be performed at the following time points: baseline (pre-and postoperative), at 6 weeks, 12 weeks, 6 months, and (12) months (for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit).
To minimize potential bias of the observational study design, a reasonable sample of investigators and sites (15-20 sites), and patients (up to 200 patients) are selected. Furthermore, data will be analyzed by an independent Contract Research Organization, and objective outcome measures are used eg, WOMAC, QuickDASH, fracture healing.
All data collected on the electronic case report forms (eCRF) for this registry will be de-identified. Each patient will be assigned to a unique reference number. eCRFs are confidential documents and will only be available to the Sponsor (including Sponsor delegates, like clinical research associates (CRAs), the Investigator, the investigation statistician, and if requested to the advisory committee, ethical committees and regulatory authorities. The key to link the unique reference number to the patient will be kept in the investigation file by the Principal Investigator for each investigation site.
Registry procedures:
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
- •Age: ≥18 years
- •Any of the following fracture types:
- •Proximal or diaphyseal humerus fracture
- •Diaphyseal or distal femur fracture
- •Diaphyseal, distal or proximal tibia fracture
- •Eligible for treatment with Synthes DLS and locked plate constructs (small or large fragments)
- •Patients able and willing to sign informed consent form
- •Patients able and willing to adhere to 12-months follow-up visits
排除标准
- •Polytrauma
- •Pregnant or nursing females
- •Patients already participating in an investigational trial
- •Patients who are not expected to survive the follow-up period
结局指标
主要结局
Radiographic callus formation and location of callus evaluation: Change over time
时间窗: 6 weeks, 12 weeks, 6 months, and (12)* months
The radiologic presence of callus at the four locations around the plate is overall evaluated by a central independent trauma fellow or radiologist: * Lateral (under the plate) * Medial (on the contra lateral cortex) * Anterior * Posterior "\*"for patients with insufficient signs of healing at the 6 months visit; otherwise preferable visit
次要结局
- Fracture union(6 weeks, 12 weeks, 6 months, and (12)* months)
- QuickDASH for patients with humerus fracture(Time point: 6 and 12 weeks, 6 and (12)* months)
- WOMAC for patients with femur and tibia fractures(Time point: 6 and 12 weeks, 6 and (12)* months)
- Full weight bearing or full use of the upper extremity(6 and 12 weeks, 6 and (12)* months)
- Adverse Events related to the device or procedure(intra-and postoperative; 6 and 12 weeks; 6 and (12)* months)
- General adverse events not related to the device or procedure(postoperative; 6 and 12 weeks; 6 and (12)* months)
- Secondary surgical interventions due to device or procedure related Adverse events(postoperative; 6 and 12 weeks; 6 and (12)* months)
- Health related quality of life: EuroQoL (EQ-5D)(Baseline; 6 and 12 weeks; 6 and (12)* months)