Intramedullary Screw Versus Kirschner Wire Fixation of Extraarticular Proximal and Middle Phalanx Fractures: Pilot Study for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Percentage of Patient Eligibility - Study Feasibility
研究概览
简要总结
When people break their fingers, sometimes surgery is needed to align the bones to heal them properly. There are different ways to fix broken bones in hands, such as plates, pins, or screws. Each method has pros and cons; fixing a broken bone with plates is usually a larger surgery with more cutting but holds the bones very securely. Pins require little to no cutting but the patient needs to immobilize their hand for a few weeks afterwards. Screws are a newer method of fixing broken fingers that requires little cutting and also holds the bones securely. The goal of this study is to compare the effectiveness of using pins versus screws in surgery for broken fingers. The investigators are studying whether using screws leads to better hand function, patient satisfaction, and quicker return to work.
详细描述
Hand fractures are one of the most common skeletal injuries and affect a wide range of the population. Commonly affected groups include children and young adults with sports-related injuries, manual labourers with work-related injuries, and the elderly. Although the majority of phalanx fractures may be managed conservatively with good outcomes, operative fixation is indicated for significantly displaced or unstable fracture patterns, and those causing malrotation and scissoring.
There are a variety of options for operative fixation of proximal and middle phalanx fractures, which include closed versus open reduction (CR vs OR) with percutaneous pinning (PP) or internal fixation (IF) techniques. Kirschner wires (K-wire) and plates/screws are the most common CRPP and ORIF techniques. K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply. However, patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection. Conversely, ORIF with plates/screws provide rigid fixation allowing for early mobilization, but require opening of fracture site and often periosteal stripping. Complications with ORIF include adhesions and stiffness.
There is emerging evidence for the effectiveness of intramedullary (IM) screw fixation as an alternative technique for IF. IM screw fixation is a minimally invasive technique that provides rigid fixation of fractures, acting as an internal splint and load-sharing device. Its biomechanical properties have been well-described in the lower extremity orthopedic literature. IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications. Small observational cohort studies have shown favourable outcomes in return to activity, range of motion, time to radiological healing, and grip strength. However, the investigators' literature search revealed a paucity of high quality studies comparing the effectiveness of IM screws with K-wires or other methods of fixation.
The primary objective of this pilot study is to assess the feasibility of a randomized controlled trial comparing two CR techniques, i.e. IM screw fixation to K-wire fixation, in adult patients with extraarticular proximal or middle phalanx fracture at the investigators' tertiary academic hospital. The secondary objective will be to describe early clinical outcomes which can be used for future trial sample size calculation.
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
- Single (Outcomes Assessor)
盲法说明
By nature of the interventions in this study, blinding will not be possible for the surgeon or the patient post-operatively.
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
- •adult patients ≥18 years old
- •scheduled for operative management of extraarticular proximal or middle closed phalanx fracture(s) at the investigators' tertiary hospital
- •feasible to perform closed reduction
- •able to provide informed consent and complete health-related quality of life (HRQoL) questionnaires in English
排除标准
- •other fractures that cannot be managed with IM screws or K-wires
- •other intraarticular fractures
- •significant concomitant hand trauma
- •cannot commit to 3 months of follow up at the investigators' institution
结局指标
主要结局
Percentage of Patient Eligibility - Study Feasibility
时间窗: 1 year
The percentage of patients that are eligible for the study among those that are screened will be recorded. This criteria will be determined to be feasible if at least 70% of screened patients are deemed to be eligible.
Recruitment rate - Study Feasibility
时间窗: 1 year
The percentage of patients that are enrolled in the study among those determined to be eligible will be recorded. To be considered fully enrolled patients must sign the informed consent form, complete baseline demographic questionnaires, and be randomized to a study arm. This criteria will be determined to be feasible if at least 70% of eligible patients are recruited.
Crossover rate - Study Feasibility
时间窗: 1 year
The percentage of patients that crossover to the other arm of the study among those who are eligible and recruited for the study. This criteria will be determined to be feasible if no more than 5% of patients cross over.
Patient retention rate - Study Feasibility
时间窗: 1 year
The percentage of patients that complete patient-reported questionnaire (Disabilities of the Arm, Shoulder, and Hand) at the 3-month mark, which will be the primary outcome of the main trial. Scores range from 0-100 points, where higher scores indicate greater disability. This criteria will be determined to be feasible if at least 80% of patients are compliant.
Compliance with intervention rate - Study Feasibility
时间窗: 1 year
The percentage of patients that comply with the intervention (appropriate post-operative care, follow-up appointments) among those who are eligible and recruited for the study. This criteria will be determined to be feasible if at least 90% of patients are compliant.
次要结局
- Disability of the Arm, Shoulder, and Hand(baseline, 4 weeks, 12 weeks)
- Range of motion(4 weeks, 8 weeks, 12 weeks)
- Grip strength(8 weeks, 12 weeks)
- Postoperative pain (visual analogue scale)(2 weeks, 4 weeks, 8 weeks, 12 weeks)
- Return to work(through study completion, an average of 3 months)
- Complications/adverse events(2 weeks, 4 weeks, 8 weeks, 12 weeks)
研究者
Helene Retrouvey
Assistant Professor
McMaster University