Zimmer® MotionLoc® in Distal Tibia Fractures: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 7
- 主要终点
- Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up
研究概览
简要总结
The objective of this observational prospective study is to systematically document the clinical outcomes of Zimmer MotionLoc Screws for Periarticular Locking Plate System applied to distal tibia fracture treatment and confirm safety and performance of the screws.
详细描述
Primary Endpoint:
- Radiographic & clinical fracture healing at 3 months post-surgery.
Secondary Endpoints:
- Complications
- Radiologic & clinical fracture healing at 6 weeks, 3, 6, and 12 months post-surgery.
- Callus size & distribution at 6 weeks, 3, 6, and 12 months post-surgery.
Radiologic fracture healing is defined as bridging of three of the four cortices as seen on x-ray/CT. Clinical healing will be assessed using the Function Index for Trauma (FIX-IT). The FIX-IT instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. It has been initially validated in patients with tibia and femur fractures.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •With or without fibula fracture involvement (treated or not treated by osteosynthesis)
- •Close or open fractures Gustilo type I
- •Unilateral or bilateral fractures
- •Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program.
- •Patients who give written consent to take part in the study by signing the "Patient Consent Form".
排除标准
- •Delay of surgery for more than two weeks.
- •Open fractures Gustilo type II & III
- •History of infection of the affected extremity
- •Non-ambulatory patients
- •Planned fixation strategy includes interfragmentary lag screw fixation of non-articular fractures.
- •Addition of bone graft, bone graft substitute or bone morphogenetic protein (BMP).
- •Immobilization with plaster.
- •Likely problems with maintaining follow-up program (e.g. patients with no fixed address, plans to move during course of study)
- •Not expected to survive the duration of follow-up program.
- •Patients known to be pregnant or breastfeeding.
- •Patients who are unwilling or unable to give consent.
结局指标
主要结局
Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 3 Months Follow-up
时间窗: 3 months
This measure will be assessed using the Function Index for Trauma (FIX-IT). The instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. Minimum (worst) score possible is 0 and Maximum (best) score possible is 12.
Number of Participants With Radiographic Fracture Healing of the Tibia at 3 Months Follow-up
时间窗: 3 months
Radiographic fracture healing is defined as bridging of three of the four cortices (as seen on x-ray/CT).
次要结局
- Complications(12 months)
- Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Weeks Follow-up(6 weeks)
- Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 6 Months Follow-up(6 months)
- Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Months Follow-up(6 months)
- Average Clinical Fracture Healing of the Tibia Using the Function Index for Trauma (FIX-IT) Score at 12 Months Follow-up(12 months)
- Number of Participants With Radiographic Fracture Healing of the Tibia at 6 Weeks Follow-up(6 weeks)
- Number of Participants With Radiographic Fracture Healing of the Tibia at 12 Months Follow-up(12 months)