Clinical trial NCT01110304: Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment
Official title: Acromio-clavicular Joint Dislocation Type III. Conservative Treatment Compared to Surgical Management With 3.5mm Clavicle Hook Plate. A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acromio-clavicular Joint Dislocation (Type III)
Keywords: acromio-clavicular joint dislocation
type III acromio-clavicular joint dislocation
joint dislocation
clavicle hook plate
Lead sponsor: Hopital de l'Enfant-Jesus
Sponsor class: OTHER
First posted: 2010-04-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Functional results of injured shoulder on Constant score
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Return to professional activities
timeFrame: 3 months after surgery
measure: Rate of secondary surgery
timeFrame: up to 12 months after surgery
measure: Social impact on SF-36 scale
timeFrame: 3 months after surgery
measure: Functional difference
timeFrame: 6 months after surgery
measure: Social impact on SF-36 scale
timeFrame: 6 months after surgery
measure: Social impact on SF-36 scale
timeFrame: 12 months after surgery
measure: Radiologic assessment on the Zanca and axillary views
timeFrame: 6 weeks after surgery
measure: Rate of complications
timeFrame: up to 12 months after surgery
measure: Pain on Visual analog scale (VAS)
timeFrame: 6 weeks after surgery
measure: Pain on VAS
timeFrame: 3 months after surgery
measure: Pain on VAS
timeFrame: 6 months after surgery
measure: Pain on VAS
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHA-Pavillon Enfant-Jésus
state: Quebec
Study officials:
affiliation: Hôpital Enfant-Jésus
name: Stéphane Pelet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Enfant-Jésus
name: Karine Sinclair, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Enfant-Jésus
name: Luc Bédard, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: