Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment
- Conditions
- Acromio-clavicular Joint Dislocation (Type III)
- Interventions
- Other: Conservative treatment - braceDevice: Hook plate by Synthes
- Registration Number
- NCT01110304
- Lead Sponsor
- Hopital de l'Enfant-Jesus
- Brief Summary
Acromio-clavicular (AC) joint dislocation corresponds to 8.6% of all joint dislocations and represents a major injury to the shoulder girdle. The nature of the treatment is decided according to the severity of the lesion.
The purpose of this study is to determine whether the surgical treatment is required or not for type III AC joint dislocations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- men or women ≥ 18 years-old;
- AC joint dislocation type III with Zanca X-ray view demonstrating CC distance of 200%;
- trauma-surgery delay of less than 14 days;
- consent form signed.
- AC joint dislocation type I, II, IV, V or VI;
- associated neuro-vascular damage;
- men or women > 60 years-old;
- open dislocation;
- local skin damage;
- dislocation in a polytrauma patient;
- floating shoulder;
- fracture of the ipsilateral or controlateral arm or shoulder girdle;
- fracture of the coracoid process of the scapula;
- history of previous surgery to the shoulder;
- medical condition preventing surgery;
- men or women unfit to consent;
- any other condition that make the examinator thinks that the follow up would be problematic.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conservative treatment Conservative treatment - brace Patients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed. Surgical treatment Hook plate by Synthes Patients will undergo surgery to treat their AC joint dislocation.
- Primary Outcome Measures
Name Time Method Functional results of injured shoulder on Constant score 3 months after surgery Based on the patient's subjective and objective answers to the Constant and Murley questionnaire, data are collected and calculated over a 100 points to measure the functional score of the injured shoulder.
Also, to measure shoulder strength, the Isoforce system from MDS® is used.
- Secondary Outcome Measures
Name Time Method Return to professional activities 3 months after surgery Evaluation of the patient's capacity to return to work and evaluating if those treated surgically return to work faster than the patients with a conservative treatment.
Rate of secondary surgery up to 12 months after surgery The difference on the reoperation rate between the two groups will be analyzed.
Social impact on SF-36 scale 12 months after surgery The social impact of both treatments will be measured with the SF-36 score.
Functional difference 6 months after surgery Using the Constant score, the functional difference between the two groups at 6 months will be measured.
Radiologic assessment on the Zanca and axillary views 6 weeks after surgery Zanca view allows control of the superior displacement. It will be expressed in percentage of the CC distance compared to the non-injured side.
Axillary view allows control of the posterior displacement. It will be expressed in percentage of the AC distance compared to the non-injured side.
Both views will assess degenerative changes, subacromial osteolysis, distal clavicle osteolysis (all expressed in percentage of patients per group).Rate of complications up to 12 months after surgery The rate of complications both general and orthopaedic will be described in the in percentage of the number of patients per group.
Pain on Visual analog scale (VAS) 6 weeks after surgery Pain is described with the VAS, which range from 1 to 10.
Pain on VAS 12 months after surgery Pain is described with the VAS, which range from 1 to 10.
Trial Locations
- Locations (1)
CHA-Pavillon Enfant-Jésus
🇨🇦Québec, Quebec, Canada