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临床试验/NCT01667887
NCT01667887已完成不适用

MotionLoc Study: Healing of Distal Femur Fractures Stabilized With a Flexible Plating Construct Using MotionLoc Screws

Legacy Biomechanics Laboratory1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
1
主要终点
Fracture Healing

研究概览

简要总结

The objective of this study is to document callus formation and healing of fractures stabilized with locking plates utilizing modern MotionLoc screws that provide controlled axial micro-motion to actively promote fracture healing.

详细描述

Rigid locked plating constructs can suppress fracture healing, particularly at the near cortex adjacent to the plate where interfragmentary motion is minimal. Dynamic fixation with Far Cortical Locking (FCL) screws reduces construct stiffness and induces axial interfragmentary motion to stimulate symmetric callus formation and healing. Two versions of FCL screws are commercially available, but the clinical durability of this novel concept has not been documented to date. This prospective observational study documented our early clinical experience with MotionLoc® FCL screws for stabilization of distal femur fractures to assess their durability and potential complications.

Thirty-two consecutive patients with 33 distal femur fractures (AO/OTA types 33-A and 33-C) were prospectively enrolled at three trauma centers. Fractures were stabilized by plate osteosynthesis with MotionLoc® FCL screws without supplemental bone graft or bone morphogenic proteins. Thirty patients with 31 fractures were available for follow-up until union or revision. Follow-up visits at 6, 12, and 24 weeks comprised functional and radiographic assessment of implant fixation and fracture healing, including computed tomography scans at week 12. The primary endpoint was fracture healing in absence of complications and revision.

There was no incidence of implant breakage or diaphyseal fixation failure. Thirty of 31 fractures healed within 15.6 ± 6.2 weeks, as evident by bridging callus and pain-free load bearing. There were two revisions, one at 5 days post surgery to correct a mal-rotation, and one at 6 months post surgery to revise a non-union. Periosteal callus distribution at week 6 was symmetrical, with similar amounts of callus at the medial cortex (35%) anterior cortex (30%) and posterior cortex (35%). In 23 fractures (74%), callus formation extended to the lateral cortex under the plate.

Absence of hardware and fixation failure suggests that dynamic plating of distal femur fractures with FCL screws provides safe and effective fixation. Moreover, the amount and symmetric distribution of periosteal callus suggests that dynamic fixation with FCL screws may promote increased fracture healing over standard locked plating. However, this hypothesis on the stimulatory effect of dynamic fixation on fracture healing requires investigation in a future randomized control trial.

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
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with distal femur fracture (AO/OTA Type 33A and 33C)
  • Patients 17 years of age and over.
  • Patients able to be operated on by selected surgeons at the participating centers.

排除标准

  • Patients who are enrolled in an investigational treatment trial.
  • Patients who are not expected to survive the follow-up period.
  • Considered an inappropriate participant by the study physician.
  • Revision surgery
  • Patients currently incarcerated or awaiting incarceration.
  • Severe spinal injury with neurological deficit resulting in paralysis.
  • Fracture fixed more then 28 days after injury.
  • Acute or chronic local or systemic infections
  • Periprosthetic fractures

结局指标

主要结局

Fracture Healing

时间窗: 6, 12, and 24 weeks post surgery

Fracture healing is defined clinically by the ability of pain-free weight bearing, and radiographically by callus formation and bridging.

次要结局

  • Periosteal Callus Size(6, 12, 24 weeks post surgery)
  • Bridging Callus from CT(12 weeks post surgery)
  • Fixation Failure(24 weeks post surgery)
  • Hardware failure(6, 12, 24 weeks post surgery)

研究者

发起方
Legacy Biomechanics Laboratory
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Bottlang, PhD

Director, Legacy Biomechanics Laboratory

Legacy Biomechanics Laboratory

研究点 (1)

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