INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 11
- 主要终点
- VAS (visual analog scale) for pain on kneeling/ability to knee
研究概览
简要总结
This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.
详细描述
There are a number of ways to approach the tibial canal when using an intramedullary nail for fracture fixation.
The gold standard is the infrapatellar approach (below the knee cap). This approach has the patient positioned with the knee flexed at 90 degrees or greater on the operating table. However, there are challenges with this approach, including imaging, placement of supplemental fixation, conversion to open reduction when necessary and malunion with apex anterior angulation for proximal tibial fractures. The positioning of the patient causes tension on the structures and soft tissues around the knee which can hinder the placement of the nail and can cause damage to the soft tissues that can result in significant long-term anterior knee pain for many patients.
The semi-extended suprapatellar approach has the patient positioned in approximately 15-20 degrees of flexion, putting less tension on the structures and soft tissues about the knee and enables the surgeon to insert the nail in an optimal position with relative ease.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all extra-articular tibial fractures
- •simple distal tibial intra-articular fractures amenable to IMN
- •open and closed fractures
- •bilateral tibiae
- •willing and able to consent, follow protocol and attend follow-up visits
- •able to read and understand English or have interpreter available
排除标准
- •patients with contralateral femur and/or hip fracture requiring retrograde IMN
- •patients with contralateral knee injuries that would impair their ability to kneel during the follow-up period
- •associated knee injury
- •previous symptomatic knee pathology
- •ipsilateral injuries to the same limb that would interfere with rehab or outcome
- •neurovascular injuries at the level of the knee requiring surgery
- •open or closed fractures > 14 days (times of injury to OR)
- •non unions
- •pathologic fractures
- •periprosthetic fractures
- •spinal injury
- •non-ambulatory patients
- •incarceration
- •limited life expectancy due to significant medical co-morbidities or medical contra-indication to surgery (pregnancy)
- •likely problems, in the judgment of the investigators, with maintaining follow-up
结局指标
主要结局
VAS (visual analog scale) for pain on kneeling/ability to knee
时间窗: 12 months post treatment
Participants assessment of their degree/level of pain on kneeling after performing the AKT (Aberdeen Kneeling Weight-Distribution Test) on a 10 cm visual analog scale
次要结局
- VAS (Visual Analog Scale) at rest, with walking and descending stairs(4, 6, 12 and 24 months post treatment)
- EQ-5D Health Related Quality of Life Outcome Measure(4, 6,12 and 24 months post treatment)
- Radiographic outcome(Intra-operatively and 4, 6,12 and 24 months post treatment)
- AKT (Aberdeen Kneeling Weight-Distribution Test)(4, 6, 12 and 24 months post treatment)
- AST (Aberdeen Standing Weight-Distribution Test)(4, 6, 12 and 24 months post treatment)
- Lysholm Knee Scoring Scale(4, 6, 12 and 24 months post treatment)
- PKPM (Photographic knee pain map)(4, 6,12 and 24 months post treatment)
- WPAI:SHP (Work Productivity and Activity Impairment: Specific Health Problem(4, 6, 12 and 24 months post treatment)