ArthroPlanner: A Surgical Planning Solution for Acromioplasty
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
- 否
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
Adrien Schwitzguebel
MD
La Tour Hospital
