Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Synthes GmbH
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
研究概览
简要总结
Case series of tibial plateau fractures using Norian Drillable.
详细描述
This study is a multi-center, non-randomized prospective case series of tibial plateau fractures using Norian Drillable to fill bone voids, to evaluate OR time, blood loss, complications, ease of use, fracture stabilization and patient function and pain over time.
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
- •Subjects with closed tibial plateau fractures classified as OTA B2, B3 or C3 resulting in a bone void.
- •At least 18 years of age.
- •Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
- •Signed informed consent.
排除标准
- •Critically ill
- •Mentally ill or mentally disordered
- •Wards of the state
- •Prisoners
- •In an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates
- •Active or suspected infection - systemic or local
- •Gustillo classification of 2 or 3
- •Bilateral tibial plateau fractures when both fracture patterns extend into the joint
- •Have an existing calcium metabolism disorder (e.g. hypercalcemia)
- •Chronic renal disease/renal failure
- •Insulin dependent diabetes
- •Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
- •Rheumatoid arthritis or other autoimmune disease.
- •Systemic disease including AIDS, HIV, hepatitis.
- •Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
- •Subjects involved in other studies within the last month, prior to screening.
- •Pregnant or interested in becoming pregnant in the next 18 months. Females of child-bearing potential must use an acceptable method of contraception during trial participation.
结局指标
主要结局
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
时间窗: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Ease of Use Score Measured With a Surgeon Questionnaire: Drill
时间窗: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
时间窗: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures.
Ease of Use Score Measured With a Surgeon Questionnaire: Tap
时间窗: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. A tap is an instrument used to create threads in a hole drilled in bone.
Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
时间窗: Day 0 (Day of surgery)
Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
时间窗: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
时间窗: Day 0 (Day of surgery)
Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)
Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
时间窗: At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
时间窗: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
时间窗: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Surgeons Overall Satisfaction With Norian Drillable
时间窗: Surgery
The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
时间窗: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
时间窗: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
次要结局
- Radiographic Parameters:: Depression at 52 Weeks(52 weeks)
- Knee Function and Stability: Extension Stability at 26 Weeks(26 weeks)
- Radiographic Parameters: Depression at Baseline(Baseline)
- Radiographic Parameters: Condylar Widening at 6 Weeks(6 weeks)
- Pain and Function Assessed With the Lysholm Knee Scale(6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only))
- Radiographic Parameters: Condylar Widening at Baseline(Baseline)
- Radiographic Parameters: Condylar Widening at 78 Weeks(78 weeks)
- Radiographic Parameters: Angulation (Valgus/Varus) at Surgery(Surgery)
- Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks(12 weeks)
- Knee Function and Stability: Extension at 78 Weeks(78 weeks)
- Knee Function and Stability: Total Range of Motion at Baseline(Baseline)
- Radiographic Parameters: Depression at 6 Weeks(6 week)
- Knee Function and Stability: Extension at 6 Weeks(6 weeks)
- Knee Function and Stability: Extension at 12 Weeks(12 weeks)
- Knee Function and Stability: Extension at 52 Weeks(52 weeks)
- Knee Function and Stability: Extension Stability at Baseline(Baseline)
- Radiographic Parameters: Depression at Surgery(Surgery)
- Radiographic Parameters: Depression at 12 Weeks(12 weeks)
- Radiographic Parameters: Depression at 26 Weeks(26 weeks)
- Radiographic Parameters: Depression at 78 Weeks(78 weeks)
- Radiographic Parameters: Condylar Widening at 26 Weeks(26 weeks)
- Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks(6 weeks)
- Knee Function and Stability: Total Range of Motion at 78 Weeks(78 weeks)
- Radiographic Parameters: Condylar Widening at Surgery(Surgery)
- Radiographic Parameters: Condylar Widening at 12 Weeks(12 weeks)
- Radiographic Parameters: Condylar Widening at 52 Weeks(52 weeks)
- Radiographic Parameters: Angulation (Valgus/Varus) at Baseline(Baseline)
- Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks(26 weeks)
- Knee Function and Stability: Extension at 26 Week(26 weeks)
- Knee Function and Stability: Extension Stability at 52 Weeks(52 weeks)
- Knee Function and Stability: Extension Stability at 78 Weeks(78 weeks)
- Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks(52 weeks)
- Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks(78 weeks)
- Knee Function and Stability: Extension at Baseline(Baseline)
- Knee Function and Stability: Total Range of Motion at 6 Weeks(6 weeks)
- Knee Function and Stability: Total Range of Motion at 12 Weeks(12 weeks)
- Knee Function and Stability: Total Range of Motion at 26 Weeks(26 weeks)
- Knee Function and Stability: Total Range of Motion at 52 Weeks(52 weeks)
- Knee Function and Stability: Extension Stability at 6 Weeks(6 weeks)
- Knee Function and Stability: Extension Stability at 12 Weeks(12 weeks)