跳至主要内容
临床试验/NCT03060564
NCT03060564Unknown不适用

A Randomized, Prospective Trial Comparing Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

Dr. Brian Lee2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
Complication Rates with and without the use of graft tendons

研究概览

简要总结

To evaluate patient function, radiographic changes and complication rates of acute coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an augmentation to repair.

详细描述

Acromioclavicular (AC) joint dislocations comprise up to 12% of shoulder girdle injuries. Many methods of reconstructing the coracoclavicular ligaments, which provide vertical stability of the acromioclavicular joint, have been described. The use of tendon graft to augment the reconstruction provides improved biomechanical stability, less radiographic changes postoperatively including loss of reduction, and improved function. However, the use of a tendon graft necessitates larger drill holes in the clavicle when compared to suture-only repair constructs. The size and placement of these tunnels in the clavicle have been associated with a higher rate of complications.

It has been shown that repairs in the setting of acute injury demonstrate less complications including loss of reduction when compared with chronic dislocations. However, other reports describing repair of acute AC joint dislocations without graft augmentation have described significant changes in coracoclavicular distance with routine follow up radiographs, and up to 90% implant migration rates. While use of tendon graft would be expected to provide further stability, they may in turn cause an increased complication rate.

  1. To determine complication rates in the reconstruction of AC joint dislocations with and without the use of tendon graft.
  2. Determine patient satisfaction, the ASES, Constant, SF-12, SANE, SST scores of shoulders that undergo reconstruction of acute AC joint dislocations with and without the use of graft.
  3. The investigation aims to determine whether or not graft should be used in the reconstruction of acute AC joint dislocations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • Displaced acromioclavicular joint dislocation sustained within 3 weeks of surgery
  • recommended for operative fixation
  • age 18 years or older

排除标准

  • Open dislocation
  • previous acromioclavicular surgery
  • unable to follow study protocol
  • concomitant injury requiring surgery (rotator cuff repair, biceps tenotomy/tenodesis)
  • active infection
  • unable to follow postoperative rehabilitation guidelines
  • reconstruction with coracoclavicular screw or hook plate.

研究组 & 干预措施

AC repair with tendon graft

Experimental

acromioclavicular repair with tendon graft.

干预措施: tendon graft (Procedure)

AC repair with no tendon graft

Active Comparator

acromioclavicular repair without tendon graft/no intervention

干预措施: No intervention (Other)

结局指标

主要结局

Complication Rates with and without the use of graft tendons

时间窗: 2 years

loss of radiographic reduction, infection, need for more surgery

(American Shoulder Elbow Society (ASES)

时间窗: 2 years

Shoulder Function survey (17 multiple choice questions).

Simple Shoulder Test (SST)

时间窗: 2 years

Shoulder Function survey (12 yes/no questions)

Visual Analog Score (VAS)

时间窗: 2 years

Measurement of shoulder pain from 0 (no pain) to 10 (unbearable distress)

Single Assessment Numerical Evaluation (SANE)

时间窗: 2 years

Patient assessment rating from 0-100 shoulder normality

Instability Index Constant Score (ISIS)

时间窗: 2 years

Shoulder Instability survey for last 4 weeks (yes/no and multiple choice). Score is graded poor, fair, good, excellent.

Short Form-12

时间窗: 2 years

This survey assesses patient's health satisfaction. This information will help keep track of how patients feel and how well patients are able to do your usual activities. (12 multiple choice questions)

次要结局

未报告次要终点

研究者

发起方
Dr. Brian Lee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Brian Lee

orthopedic surgeon specializing in arthroscopic and open surgery of all conditions of the shoulder and elbow including arthritis, tendon disorders, fractures, and instability

Cedars-Sinai Medical Center

研究点 (2)

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