NCT02579694终止不适用
Multicenter Retrospective-prospective Short-term Evaluation of the SLIC Screw System in Subjects Requiring Treatment for Acute Scapholunate Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Acumed, LLC
- 入组人数
- 9
- 主要终点
- Comparison of reported VAS pain from preoperative to post-planned explantation
研究概览
简要总结
The purpose of this retrospective-prospective clinical evaluation is to determine whether the SLIC Screw System provides provisional fixation to allow biological healing of the scapholunate interval.
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
- •Subjects willing and able to comprehend and sign Informed Consent
- •Subjects who have received the SLIC screw as part of the treatment for scapholunate ligament repair or scapholunate reduction
- •Subjects with acute scapholunate injury, classified with Garcia-Elias Stage 1-4, OR Geissler Stage 1-3
- •Subjects >18 years of age at the time of surgery
排除标准
- •Subject diagnosed with chronic scapholunate injury
- •Subjects who underwent previous scapholunate procedure on the study wrist before implantation of the SLIC Screw System
- •Subjects with active or latent infection at the time of surgery
- •Subjects with sepsis at the time of surgery
- •Subjects diagnosed with osteoporosis at the time of surgery
- •Subjects with insufficient quantity and/or quality of bone
- •Subjects with cartilage degeneration on the bones at the time of surgery
- •Subjects with absence of potential for soft tissue healing at time of surgery, as documented by the investigator.
- •Female Subjects known to be pregnant
- •Subjects who were unable to follow postoperative care instructions, specifically, activity levels
- •Subjects who are unable or unwilling to return for postoperative study visits
结局指标
主要结局
Comparison of reported VAS pain from preoperative to post-planned explantation
时间窗: 12 months
Planned removal of provisional device recommended between six and 9 months; 12-month analysis will capture time to planned removal.
Time to planned explantation is operationally defined as the time in days between device implantation and planned removal of an intact device
时间窗: 12 months
The proportion of devices where removal is attributed to healing and not device failure
时间窗: 12 months
次要结局
- Radiographic evaluation of device integrity(12 months)
- Radiographic evaluation of radiolucency(12 months)
- Radiographic evaluation of osteolysis(12 months)
- Complication rates over time(12 months)
- Comparison of range of motion in degrees from preoperative values(12 months)
- Comparison of grip strength in kg from preoperative values(12 months)
- Comparison of reported VAS pain from preoperative values(12 months)
- Subject satisfaction based on a five-point scale from preoperative(12 months)
- Comparison of scapholunate angle from preoperative through radiographic evaluation(12 months)
- Comparison of scapholunate joint space from preoperative through radiographic evaluation(12 months)
研究者
相似试验
已完成
不适用
Total Hip Arthroplasty (THA) Surgical Techniques Comparing the Direct Anterior Approach to the Posterior ApproachOsteoarthritis of the HipNCT01807104Barrett, William, M.D.87
已完成
不适用
Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-upPresbyopiaNCT06310252Allotex, Inc.71
进行中（未招募）
不适用
Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral StemArthroplasty, Replacement, HipNCT02371382Zimmer Biomet250
终止
不适用
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior FixationDegenerative Disc DiseaseNCT02068768LDR Spine USA13
尚未招募
不适用
Evaluation of Remote Monitoring of Liver Cirrhosis PatientsLiver CirrhosisNCT06746246Maastricht University Medical Center750