A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 3
- 主要终点
- SF-36
研究概览
简要总结
This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
详细描述
Eligible patients will be randomized to one of two treatment arms: Hardware removal at 6 months or Hardware retention for a minimum of 2 years.
Consenting patients having previously undergone open reduction and internal fixation of Lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms: removal hardware (RH) or hardware retention (HR).
Outcome will be assessed at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years from enrollment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has Lisfranc injury that was treated within 28 days of injury.
- •Subject must be enrolled in study between 6 and 8 weeks from time of initial fixation operation.
- •The patient must be medically fit for anesthesia
- •Subject is willing and able to provide written informed consent for trial participation
- •Subject is willing and able to comply with the study protocol including return for all follow-up evaluations
- •Subject may have a bony, ligamentous, or combined lisfranc injury
- •Demonstrated instability of the lisfranc complex on static, stress view or CT radiography.
- •Associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon
- •Adequate reduction to within 1mm of lisfranc complex at time of fixation
- •Hardware across the midfoot (tarsal-metatarsal joints 1-3)
排除标准
- •Subject has a significant pre-existing foot injury
- •Subject has a delay in initial treatment greater than 28 days from time of injury
- •Subject has an active infection in the area of surgical approach requiring surgical debridement
- •Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time (another long bone fracture, ipsilateral limb injury)
- •Subject has a history of rheumatoid arthritis, Diabetes, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis or any other pre-existing pathologic condition affecting the Lisfranc complex
- •Subject has a high risk of death from surgery (ASA physical status Class V)
- •Subject is likely unable to maintain follow-up(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.)
- •Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires
- •Subject is pregnant
- •There has been loss of fixation or reduction prior to enrollment
- •Previous corrective foot surgery
- •Associated fracture of calcaneus, talus, or tibial plafond.
- •Pathologic fracture
- •Loss of fixation or reduction prior to enrollment
结局指标
主要结局
SF-36
时间窗: 2 years
Patient reported measure on physical and mental status on 36 items across eight health domains.
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
时间窗: 2 years
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
VAS-FA - Visual Analog Scale Foot and Ankle
时间窗: 2 years
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
VAS - Visual Analogue Scale (Patient Satisfaction)
时间窗: 2 years
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
次要结局
- Cost-effectiveness(2 years)
- Radiologic outcome(2 years)
研究者
Paul Duffy
Division Head, Orthopaedic Trauma
University of Calgary