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

NCT ID: NCT01110304

Last Updated: 2012-12-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2015-02-28

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)

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conservative treatment

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

Group Type: ACTIVE_COMPARATOR

Conservative treatment - brace

Intervention Type: OTHER

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.

Surgical treatment

Patients will undergo surgery to treat their AC joint dislocation.

Group Type: ACTIVE_COMPARATOR

Hook plate by Synthes

Intervention Type: DEVICE

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.

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

brace and analgesics; hook plate surgery

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital de l'Enfant-Jesus

OTHER

Sponsor Role: lead

Responsible Party

Pelet Stephane

Dr Stephane Pelet MD, PhD Orthopedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stéphane Pelet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Enfant-Jésus

Karine Sinclair, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Hôpital Enfant-Jésus

Luc Bédard, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Hôpital Enfant-Jésus

Locations

CHA-Pavillon Enfant-Jésus

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Hélène Côté, Reg. Nurse

Role: CONTACT

Phone: 418-649-0252

Email: helco3@hotmail.com

Stéphane Pelet, MD, PhD

Role: CONTACT

Phone: 418-649-0252

Email: stephane.pelet.ortho@gmail.com

Facility Contacts

Stéphane Pelet, MD, PhD

Role: primary

Other Identifiers

PEJ-337

Identifier Type: -

Identifier Source: org_study_id