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

H

Hopital de l'Enfant-Jesus

Status

Unknown

Conditions

Acromio-clavicular Joint Dislocation (Type III)

Treatments

Other: Conservative treatment - brace
Device: Hook plate by Synthes

Study type

Interventional

Funder types

Other

Identifiers

NCT01110304
PEJ-337

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

56 participants in 2 patient groups

Conservative treatment
Active Comparator group
Description:
Patients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed.
Treatment:
Other: Conservative treatment - brace
Surgical treatment
Active Comparator group
Description:
Patients will undergo surgery to treat their AC joint dislocation.
Treatment:
Device: Hook plate by Synthes

Trial contacts and locations

1

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Central trial contact

Stéphane Pelet, MD, PhD; Hélène Côté, Reg. Nurse

Data sourced from clinicaltrials.gov

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