Clinical Trials Directory

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UnknownNCT01110304

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
56 (estimated)
Sponsor
Hopital de l'Enfant-Jesus · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERConservative treatment - bracePatients 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.
DEVICEHook plate by SynthesThe 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.

Timeline

Start date
2007-05-01
Primary completion
2013-02-01
Completion
2015-02-01
First posted
2010-04-26
Last updated
2012-12-20

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01110304. Inclusion in this directory is not an endorsement.