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

NCT01110304 | Unknown

• 1 other identifier: PEJ-337
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Functional results of injured shoulder on Constant score

  Based 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.

  3 months after surgery

Secondary Outcomes (12)

• Return to professional activities

  3 months after surgery

• Rate of secondary surgery

  up to 12 months after surgery

• Social impact on SF-36 scale

  3 months after surgery

• Functional difference

  6 months after surgery

• Social impact on SF-36 scale

  6 months after surgery

Study Arms (2)

Conservative treatment

ACTIVE COMPARATOR

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

Other: Conservative treatment - brace

Surgical treatment

ACTIVE COMPARATOR

Patients will undergo surgery to treat their AC joint dislocation.

Device: Hook plate by Synthes

Interventions

Conservative treatment - brace 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.

Also known as: brace and analgesics

Conservative treatment

Hook plate by Synthes 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.

Also known as: hook plate surgery

Surgical treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital de l'Enfant-Jesus: lead

Study Sites (1)

CHA-Pavillon Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada

RECRUITING

MeSH Terms

Conditions

Joint Dislocations

Interventions

Braces; Analgesics

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Stéphane Pelet, MD, PhD

  Hôpital Enfant-Jésus

  PRINCIPAL INVESTIGATOR

• Karine Sinclair, MD, FRCSC

  Hôpital Enfant-Jésus

  PRINCIPAL INVESTIGATOR

• Luc Bédard, MD, FRCSC

  Hôpital Enfant-Jésus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hélène Côté, Reg. Nurse

CONTACT

418-649-0252; helco3@hotmail.com

Stéphane Pelet, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Stephane Pelet MD, PhD Orthopedic surgeon

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 26, 2010
• Study Start: May 1, 2007
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2015
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

CA (1)