A Prospective, Randomised 18 -Year Follow-up Study of Operative and Non-operative Treatment of Acute, Total Acromioclavicular Dislocation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Presence of delayed surgical procedure to treat the AC joint dislocation pathology
研究概览
简要总结
The purpose of this study is to compare the long-term clinical and radiological results of operative and conservative treatment of Tossy type 3 acromio-clavicular dislocation.
详细描述
The optimal treatment of Rockwood type 3 AC joint injuries is still controversial. This controversy results from the low level of evidence of the early literature and the evaluation of all AC joint injuries with a type I through III classification system.
There are no prospective randomized controlled long-term studies on the treatment of Tossy type 3 AC dislocation using primary repair and minimal pin fixation.
In this study, the non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The surgical treatment consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Tossy grade 3 AC-dislocation was recruited between the years 1989 and 1991 at Kuopio University Hospital for a randomized controlled study
- •A written informed consent.
排除标准
- •Not written informed consent
研究组 & 干预措施
2 Surgical group
The surgical treatment was accomplished within two days after the injury, and it consisted of an open reduction and fixation of the AC joint with two smooth Kirschner wires (2 mm in diameter) across the AC-joint. The K-wires were bent at the proximal ends, with suturing of the superior AC ligament. The position of Kirschner wires was confirmed during the operation using C-arm transillumination. The articular disc of AC joint was removed if it was damaged. Postoperative care consisted of immobilisation of the AC joint in a sling, (Polysling, body band) for four weeks and the mobilisation of the shoulder started four to six weeks later in a similar manner as in the non-operative group.
干预措施: Surgical group (Procedure)
1. Non-surgical group
The non-surgical treatment consisted of immobilisation of the injured AC-joint in a Kenny-Howard-type splint for four weeks. The patient was encouraged in mobilisation of the elbow several times per day and the mobilisation of the shoulder with pendulum type movements were initiated four weeks after the injury. Active mobilisation of the shoulder was allowed six weeks after the injury.
干预措施: Non-surgical group (Procedure)
结局指标
主要结局
Presence of delayed surgical procedure to treat the AC joint dislocation pathology
时间窗: from 18 to 20 years
次要结局
- UCLA score(18-20 years)
- Osteoarthrosis using modified Kellgren-Lawrence classification for follow-up radiographs(18-20 years)
- The source (mechanism) of the AC dislocation injury (eg. falling, collision(0 day)
- Patient weight (kg)(18 - 20 years)
- Oxford score(18-20 years)
- Instability experiences of the AC joint (none, sometimes = less than 10 times a year, often = more than 10 times year)(18-20 years)
- Palpation of the AC joint (normal, prominent but stable, unstable)(18-20 years)
- Cross arm test (pain in AC joint, no/yes)(18-20 years)
- Grading of the AC dislocation using Rockwood classification (3-6)(18-20 years)
- Osteolysis of clavicle (none, mild, moderate, severe) for follow-up radiographs(18-20 years)
- Presence of other pathologic conditions or operative treatments for the shoulder, AC joint or other part of shoulder, description of it(18 - 20 years)
- Larsen score(18-20 years)
- Pain (VAS, cm) related to instability experience of AC joint(18-30 years)
- Range of motion of the shoulder (flexion, abduction, horizontal adduction, degrees(18-20 years)
- AC joint width in the middle of the joint (mm)(18-20 years)
- Distance between proc. coracoideus and clavicle (coracoclavicular interspace) in Zanca projection, compared to non-injured side(mm)(18-20 years)
- Other pathologic condition of the shoulder (eg. osteoarthrosis of the glenohumeral joint, elevation of the humerus, calcific deposits of cuff) and the description of it(18-20 years)
- Patient length (cm)(18 - 20 years)
- Grading of the work (light, heavy work, retired)(18 - 20 years)
- Other pathologic findings of the shoulder in the clinical examination and the description of it(18-20 years)
- Presence of calcification of CC ligaments (yes/no)(18-20 years)
- Patient age at the time of injury (years)(0 day)
- Occupation(18 - 20 years)
- Simple Shoulder Test (SST)(18-20 years)
- Constant score(18-20 years)
- Pain of palpation (no or yes)(18-20 years)
研究者
Antti Joukainen
MD, PhD
Kuopio University Hospital