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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01110304
Enrollment
56
Registered
2010-04-26
Start date
2007-05-31
Completion date
2015-02-28
Last updated
2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromio-clavicular Joint Dislocation (Type III)

Keywords

acromio-clavicular joint dislocation, type III acromio-clavicular joint dislocation, joint dislocation, clavicle hook plate

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.

Interventions

OTHERConservative 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.

DEVICEHook 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.

Sponsors

Hopital de l'Enfant-Jesus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional results of injured shoulder on Constant score3 months after surgeryBased 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

MeasureTime frameDescription
Rate of secondary surgeryup to 12 months after surgeryThe difference on the reoperation rate between the two groups will be analyzed.
Social impact on SF-36 scale3 months after surgeryThe social impact of both treatments will be measured with the SF-36 score.
Functional difference6 months after surgeryUsing the Constant score, the functional difference between the two groups at 6 months will be measured.
Return to professional activities3 months after surgeryEvaluation 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 complicationsup to 12 months after surgeryThe 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 surgeryPain is described with the VAS, which range from 1 to 10.
Pain on VAS3 months after surgeryPain is described with the VAS, which range from 1 to 10.
Radiologic assessment on the Zanca and axillary views6 weeks after surgeryZanca 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).

Countries

Canada

Contacts

Primary ContactHélène Côté, Reg. Nurse
helco3@hotmail.com418-649-0252
Backup ContactStéphane Pelet, MD, PhD
stephane.pelet.ortho@gmail.com418-649-0252

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026