Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- residual postoperative knee pain
研究概览
简要总结
This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.
详细描述
Patients undergoing tibial fracture repair will be consented and randomized into one of the two techniques, with arthroscopic photos taken before and after nail insertion to study the condition of the patello-femoral cartilage. Enrolled patients will be followed for one year in clinic.
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
- •Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming
- •Acute tibial fractures within 4 weeks of injury
- •Closed or open tibial fractures after appropriate irrigation and debridement
- •Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia
- •Skeletally mature patient
- •Age 18 and above.
排除标准
- •Tibial shaft fractures that require articular reconstruction with plates
- •Any tibial fracture extending > 1 cm into the proximal or distal 1/5 of tibia
- •Tibial plateau fractures
- •Pilon fractures
- •Periprosthetic fractures
- •Non-unions
- •Prior knee surgery
- •History of gout or rheumatoid or osteoarthritis
- •Concomitant injury to same limb (including any traumatic injury to ipsilateral knee, femur or foot, and knee dislocation)
- •Spinal injury
- •Prisoner or high likelihood of incarceration
- •Not likely to follow-up in the estimation of surgeon
- •Pregnant females
结局指标
主要结局
residual postoperative knee pain
时间窗: 1 year
A Visual Analog Scale (VAS) will be used for knee pain, as well as a pain location diagram and a Lysholm knee score.
次要结局
- union/alignment of tibia(3 months postoperatively)
- knee function(6 months postoperatively)
- trochlear changes in the patello-femoral cartilage(1 year)