跳至主要内容
临床试验/NCT00716508
NCT00716508终止4 期

Surgical Treatment for Acute Patella Tendon Rupture: a Prospective, Randomized Study Comparing Transpatellar Suture Tunnels Method vs. Suture Anchors.

Emory University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
3
试验地点
2
主要终点
Outcome measures will include SF 36, Tegner and Lysholm scores, as well as IKDC scores.

研究概览

简要总结

We will compare two groups for acute patella tendon repair: one treated with surgical anchors and the second, with transpatellar tunnels.

详细描述

The patella tendon is located in the knee, and is attached to the leg bone and the patella bone (knee cap). The quadriceps muscle (an important tight muscle) attaches to the patella bone and allows for extension and flexion of the leg. Rupture of the patella tendon occurs mainly in people under the age of 40 years old with an active lifestyle. Normally, surgical repair is needed to fix this injury. The widely accepted surgery for this injury consists in drilling 2 holes in the patella bone that are used to anchor the patella tendon in place. This surgery has some complications such as re-rupture of the tendon, breakage of the bone, etc. Some investigators have tried different techniques to avoid these complications with variable results. We want to use 2 anchors in the bone to avoid making holes in the patella bone, decreasing complications and surgical time, and hopefully, allowing for a better surgical repair. We will have 2 arms. One group will have the standard of care technique and the second group will have the anchors technique. We will follow up with our patients after the surgery to record their progress, and complications, if any. We will also have a standardized physical therapy program for consistency and to avoid any problems.

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

入选标准

  • Stage of Disease: Acute ruptures of the patella tendon, no more than 3 weeks since the time of injury.
  • Age: 18 years old and up.
  • Performance status: Patients with no other previous illnesses that prevented them to ambulate normally (without help of devices).
  • Informed consent requirements: One person from our research staff will approach the patient after the diagnosis has been made. The diagnosis will be made by the doctor in charge on the patient care based on the medical history, physical exam and image studies (MRI). We will explain the benefits/risks to be part of the study and that they are not obligated to be part of it as part of their care.

排除标准

  • Prior treatment: Patients with chronic patella tendon ruptures (more than 3 weeks).
  • Prior other diseases: diseases with systemic collagen deficiencies.
  • Infection: Patients with active infection will be disqualified.

结局指标

主要结局

Outcome measures will include SF 36, Tegner and Lysholm scores, as well as IKDC scores.

时间窗: Weeks 0-3, 4-6, 7-8, 12 and 16-24 after surgery:

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyle Webb

Research Administrator

Emory University

研究点 (2)

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