Recruiting

Conservative Treatment vs. Surgical Hook Plate

Sponsor:

Hopital de l'Enfant-Jesus

Code:

NCT01110304

Conditions

Acromio-clavicular Joint Dislocation (Type III)

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Conservative treatment - brace

Hook plate by Synthes

Study Details

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.

Conditions

Acromio-clavicular Joint Dislocation (Type III)

Study ID

NCT01110304

Start date

May, 2007

Status verified date

Dec, 2012

Completion date

Feb, 2015

Anticipated

Primary completion date

Feb, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Conservative treatment

Patients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed.

active comparator: Surgical treatment

Patients will undergo surgery to treat their AC joint dislocation.

Interventions

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.

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.

Primary outcome measure

  • Functional results of injured shoulder on Constant score [ Time Frame: 3 months after surgery ]

Central Contacts and Locations

Central contacts

Hélène Côté, Reg. Nurse

418-649-0252helco3@hotmail.com

Stéphane Pelet, MD, PhD

418-649-0252stephane.pelet.ortho@gmail.com

Locations

CHA-Pavillon Enfant-Jésus

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

Stéphane Pelet, MD, PhD

418-649-0252stephane.pelet.ortho@gmail.com

Principal Investigator:

Stéphane Pelet, MD, PhD

More Information

Sponsor

Hopital de l'Enfant-Jesus

Last update posted

Dec 20, 2012

Last verified

Dec, 2012

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hopital de l'Enfant-Jesus on 2012-12-20.