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临床试验/NCT02725346
NCT02725346Unknown不适用

ArthroPlanner: A Surgical Planning Solution for Acromioplasty

Adrien Schwitzguebel2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2015年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
67
试验地点
2
主要终点
Volume in mm3 of bone removal in four zones determine between pre- and postoperative computed tomography

研究概览

简要总结

A computer-assisted solution for acromioplasty is presented. The software allows surgeons to better plan the surgical procedure by visualizing dynamic simulation of the patient's shoulder joint during everyday activities. Impingements are dynamically detected and the exact location and amount of bone to be resected is precisely computed. As a result, the success of the acromioplasty does not only rely on the surgeon's experience or previous recommendations, but on quantitative data. Although the clinical validation of this 3D planning support is currently under evaluation, it may allow to recover more effectively postoperative joint mobility, to get a better relationship with pain and a better healing rate of the rotator cuff tendons.

详细描述

Introduction Subacromial impingement of the rotator cuff between the anterior [1] or lateral acromion [2] and the superior humeral head is a common disorder. This condition arises when the subacromial space height is too narrow during active elevation or scaption of the arm above shoulder level due to an abnormal hooked shape or large lateral extension of the acromion.

In severe cases of impingement syndrome, an arthroscopic acromioplasty surgery is usually performed to resect the different area of the acromion causing damage to the subacromial structures. The exact location and the amount of bone to be resected is generally left to the unique appreciation of the orthopedic surgeon during surgery. To improve the precision of this resection, surgeons could greatly benefit from a surgical planning solution that aims at providing precise information about the surgical procedure. Moreover, since subacromial impingements are the result of a dynamic mechanism, an effective planning solution should analyze both the morphological joint's structures and its dynamic behavior during shoulder movements to fully apprehend the patient joint's condition.

Computer-assisted planning solution "ArthroPlanner" for acromioplasty is nowadays available. The solution allows to perform standard morphological bony measurements, as well as 3D simulations of the patient's joint during everyday shoulder activities. The software computes the precise bone resection (location and amount) based on detected subacromial impingements during motion.

The goal of this study was thus to compare clinical and radiological results of superior rotator cuff repair with or without computer-assisted planning. The hypothesis was that preoperative planning of acromioplasty would allowed more accurate bone resection, would decrease postoperative impingements and consequently improved postoperative range of motion and tendon healing.

Methods

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Arthroscopic supraspinatus repair

排除标准

  • Incomplete documentation
  • Follow-up of less than six months
  • Previous shoulder surgery
  • Contraindications for computed tomography

结局指标

主要结局

Volume in mm3 of bone removal in four zones determine between pre- and postoperative computed tomography

时间窗: 6 months

Accuracy of acromioplasty in relation to preoperative planning (zone 1 anterior, zone 2 lateral, zone 3 medial, zone 4 central).

Tendon healing determine with ultrasound with Sugaya criteria

时间窗: 6 month

ultrasound realized by a blinded radiologist. This outcome will be considered as primary only if the first primary outcome is reached. Otherwise it will considered as a secondary outcome.

次要结局

  • American Shoulder and Elbow Surgeons score(6 months)
  • Simple shoulder value(6 months)
  • Percentage of gain of range of motion between groups of postoperative range of motion(6 month)
  • Single Assessment Numeric Evaluation score(6 months)
  • Constant score(6 months)

研究者

发起方
Adrien Schwitzguebel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Adrien Schwitzguebel

MD

La Tour Hospital

研究点 (2)

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