A Randomized, Prospective Comparison of Stainless Steel and Bioabsorbable Screw Fixation of Lisfranc Foot Injuries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Foot and Ankle Ability Measures
研究概览
简要总结
I hypothesize that absorbable screw fixation of the foot's Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw is not necessary.
详细描述
The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot.
When the Lisfranc ligaments are disrupted, the stability it had given to the middle of the foot is lost. Attempted activity at the foot will result in pain and abnormal motion. If injury to the Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and deformity.
The current standard orthopaedic treatment of Lisfranc ligament injuries is surgery. The Lisfranc ligaments are fixed by compressing the space between the middle bones of the foot with steel screws. These screws allow for ligament healing. As the ligaments heal, the patient should not resume activity with the fixed foot too soon as the screw may break. A second surgical procedure is often recommended to remove the screw 6 months after surgery. This allows for a complete return of normal foot range of motion, but at the cost of a second procedure.
The use of materials that can be absorbed by the human body to fix the Lisfranc ligaments has only been studied in 1 paper. One such material is the Smart Screw (Bionx, Blue Bell, Pennsylvania) which is approved by the Food and Drug Administration (F.D.A.) and made of polylevolactic acid (PLA). Absorbable screws could be ideal for the treatment of Lisfranc ligament injuries.
Comparing the long-term results of fixing the Lisfranc ligaments with either a steel or absorbable screw is important as there are no studies on the subject to date. There is only 1 published study regarding absorbable screws to fix the Lisfranc ligaments. The purpose of this study is to compare the outcome of steel and absorbable screw fixation of the Lisfranc ligaments in foot injuries in one surgeon's (J.A.) practice at Thomas Jefferson University Hospital, Riddle Memorial Hospital, and Nazareth Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be adults of any gender or race.
- •Subjects will be adults between 18 and 75 years of age.
- •The underlying diagnosis will be a Lisfranc foot injury.
- •The indication for fixing the Lisfranc ligaments is abnormal separation of the middle part of the foot from each other.
- •Subjects will have received either a steel or absorbable screw to fix the Lisfranc ligaments.
排除标准
- •Subjects may not have any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures.
- •Subjects may not have a history of known alcohol, analgesic, or narcotic substance abuse within 12 months prior to pretreatment.
- •Subjects may not have a history of severe psychiatric illness such as depression or psychosis that may influence the results of administered outcome questionnaires.
- •Subjects may not be pregnant.
- •Subjects may be excluded from this study for any reason that may pose unnecessary risk or confounding of data, in the judgment of the investigator. This includes the 4 above points.
- •Subjects must not have intact or normal Lisfranc ligaments in the foot.
- •Subjects may not have a history of deep Lisfranc joint infection.
结局指标
主要结局
Foot and Ankle Ability Measures
时间窗: 3 years
次要结局
- X-rays for maintained healing(3 years)
- Visual Analog Score for pain(3 years)
研究者
Jamal Ahmad
Assistant Professor of Orthopaedic Surgery
Rothman Institute Orthopaedics