Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment

Acromio-clavicular Joint Dislocation (Type III) Clinical Trial

Official title:

Acromio-clavicular Joint Dislocation Type III. Conservative Treatment Compared to Surgical Management With 3.5mm Clavicle Hook Plate. A Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01110304
• Other study ID #: PEJ-337
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2010
• Last updated: December 19, 2012
• Start date: May 2007
• Est. completion date: February 2015

Study information

• Verified date: December 2012
• Source: Hopital de l'Enfant-Jesus
• Contact: Hélène Côté, Reg. Nurse
• Phone: 418-649-0252
• Email: helco3[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: February 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromio-clavicular Joint Dislocation (Type III)
• Dislocations

Intervention

Other:
• Conservative treatment - brace
Patients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed. They can move the elbow, the wrist and the fingers immediately. After two weeks, they will begin a training program to restore shoulder motion and strength, and they will be asked to take off the brace progressively. They are allowed to start working and sporting activities when they feel comfortable.

Device:
• Hook plate by Synthes
The patient is in a beach-chair position with injured arm slightly out of the table, on a bracket. The incision is longitudinal, from the distal third of the clavicle to the lateral border of the acromion. The deltoid is detached anteriorly to present the clavicle and the AC joint. The width of the hook depends on the depth of the acromion. The plate will always be 5 holes 3.5mm hook plate (Synthes®), left or right. The hook is inserted after visual reduction of the AC joint at the posterior border of the distal end of the clavicle, under the acromion. Reduction is then maintained by a davier and fixation with three 3,5mm cortical screws is achieved. After washing, deltoid is reinserted. CC ligaments are not directly repaired. Wound closure and bracing for two weeks.

Locations

Country	Name	City	State
Canada	CHA-Pavillon Enfant-Jésus	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital de l'Enfant-Jesus

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional results of injured shoulder on Constant score	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.	3 months after surgery	No
Secondary	Return to professional activities	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.	3 months after surgery	No
Secondary	Rate of secondary surgery	The difference on the reoperation rate between the two groups will be analyzed.	up to 12 months after surgery	No
Secondary	Social impact on SF-36 scale	The social impact of both treatments will be measured with the SF-36 score.	3 months after surgery	No
Secondary	Functional difference	Using the Constant score, the functional difference between the two groups at 6 months will be measured.	6 months after surgery	No
Secondary	Social impact on SF-36 scale	The social impact of both treatments will be measured with the SF-36 score.	6 months after surgery	No
Secondary	Social impact on SF-36 scale	The social impact of both treatments will be measured with the SF-36 score.	12 months after surgery	No
Secondary	Radiologic assessment on the Zanca and axillary views	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).	6 weeks after surgery	No
Secondary	Rate of complications	The rate of complications both general and orthopaedic will be described in the in percentage of the number of patients per group.	up to 12 months after surgery	No
Secondary	Pain on Visual analog scale (VAS)	Pain is described with the VAS, which range from 1 to 10.	6 weeks after surgery	No
Secondary	Pain on VAS	Pain is described with the VAS, which range from 1 to 10.	3 months after surgery	No
Secondary	Pain on VAS	Pain is described with the VAS, which range from 1 to 10.	6 months after surgery	No
Secondary	Pain on VAS	Pain is described with the VAS, which range from 1 to 10.	12 months after surgery	No