Study of Locked Plates Versus Intramedullary Nails in Distal Femur Fractures: A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation (S.O.L.V.E.D)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 43
- 主要终点
- Short Musculoskeletal Functional Assessment (SMFA) Score
研究概览
简要总结
This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.
详细描述
The study is a randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature
- •Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA
- •Fracture requiring operative treatment amenable to either IM nail or plate
- •Informed consent obtained
- •Patient is English speaking
排除标准
- •Fracture of the metaphyseal distal femur with intra-articular communition,
- •Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair,
- •Pathological fracture,
- •Known metabolic bone disease,
- •Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee
- •Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
- •Symptomatic knee arthritis
- •Soft tissue injuries compromising either treatment method with nail or plate
- •Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures
- •Immunocompromised
- •Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired)
- •Current or impending incarceration
- •Unlikely to follow-up in surgeon's estimation
结局指标
主要结局
Short Musculoskeletal Functional Assessment (SMFA) Score
时间窗: 3 months, 6 months, 12 months
The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.
EQ Index
时间窗: 3 months, 6 months, 12 months
EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.
SMFA - Bother Index
时间窗: 3 months, 6 months, 12 months
The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.
EQ-5D
时间窗: 3 months, 6 months, 12 months
EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.
次要结局
- Valgus of Over 5 Degrees(12 months)
研究者
Paul Tornetta, III, M.D.
Paul Tornetta,III,M.D
Boston Medical Center