The Effect of Knee Immobilization on Postoperative Pain Following an Anterior Cruciate Ligament (ACL) Reconstruction: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at forty eight hours postoperative.
研究概览
简要总结
The purpose of the study is to determine if there is difference in immediate postoperative pain levels (48 hours) between patients who wear a knee immobilizer splint compared to patients who do not wear a knee immobilizer splint after an anterior cruciate ligament reconstruction surgery.
详细描述
This study will attempt to evaluate the efficacy of knee immobilization on patient postoperative pain levels following an ACL reconstruction. There is a lack of consensus in the area of postoperative knee bracing/immobilization. A survey of Canadian surgeons indicates that the primary reason for postoperative knee immobilization is to reduce pain. To the investigators' knowledge, there are no studies comparing the use of immediate (0-48 hours) postoperative knee immobilization versus no immobilization and pain control in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Clinical: Patients' aged 18-40, ACL deficiency as determined by MRI or physical exam (positive lachmann and pivot shift tests) resulting in giving way episodes (acute or chronic) unresponsive to non-operative management and therefore requiring primary ACL reconstruction.
- •- Arthroscopic: Concomitant meniscal resection.
排除标准
- •- Clinical: Previous surgery on either knee (not including a diagnostic arthroscopy arthroscopy or simple partial meniscectomy,) Concomitant lower extremity fracture, Ipsilateral collateral ligament injury within past 3 months, Time from ACL injury less than 6 weeks, Allergy/intolerance to Tylenol 3 with codeine and to Percocet, Third Party or Medical Legal.
- •- Radiological: Skeletal immaturity (open growth plates).
- •- Arthroscopic/surgical: Concomitant posterior cruciate ligament or collateral ligament repairs, Osteochondral lesions requiring microfracture, Meniscal repair, Patients not having both their semitendinosus and gracilis harvested.
结局指标
主要结局
Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at forty eight hours postoperative.
次要结局
- Patient self-assessed pain levels using an unmarked zero to one hundred mm visual analog scale (VAS) at seven and fourteen days postoperative.
- Analgesic type and time taken will be self reported by the patient at each VAS entry.
- Range of motion including both flexion and extension will be assessed at fourteen days postoperative by the surgeon.