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

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.

Study Overview

• Status: Unknown
• Conditions: Acromio-clavicular Joint Dislocation (Type III)
• Intervention / Treatment: Other: Conservative treatment - brace; Device: Hook plate by Synthes

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1J 1Z4
      • Recruiting
      • CHA-Pavillon Enfant-Jésus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conservative treatment; Patients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed.	Other: 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.; Other Names: brace and analgesics
Active Comparator: Surgical treatment; Patients will undergo surgery to treat their AC joint dislocation.	Device: 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.; Other Names: hook plate surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return to professional activities	Evaluation 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.	3 months after surgery
Rate of secondary surgery	The difference on the reoperation rate between the two groups will be analyzed.	up to 12 months after surgery
Social impact on SF-36 scale	The social impact of both treatments will be measured with the SF-36 score.	3 months after surgery
Functional difference	Using the Constant score, the functional difference between the two groups at 6 months will be measured.	6 months after surgery
Social impact on SF-36 scale	The social impact of both treatments will be measured with the SF-36 score.	6 months after surgery
Social impact on SF-36 scale	The social impact of both treatments will be measured with the SF-36 score.	12 months after surgery
Radiologic assessment on the Zanca and axillary views	Zanca 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).	6 weeks after surgery
Rate of complications	The rate of complications both general and orthopaedic will be described in the in percentage of the number of patients per group.	up to 12 months after surgery
Pain on Visual analog scale (VAS)	Pain is described with the VAS, which range from 1 to 10.	6 weeks after surgery
Pain on VAS	Pain is described with the VAS, which range from 1 to 10.	3 months after surgery
Pain on VAS	Pain is described with the VAS, which range from 1 to 10.	6 months after surgery
Pain on VAS	Pain is described with the VAS, which range from 1 to 10.	12 months after surgery

Collaborators and Investigators

• Sponsor: Hopital de l'Enfant-Jesus
• Investigators: Principal Investigator: Karine Sinclair, MD, FRCSC, Hôpital Enfant-Jésus; Principal Investigator: Luc Bédard, MD, FRCSC, Hôpital Enfant-Jésus

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 23, 2010
• First Posted (Estimate): April 26, 2010

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: acromio-clavicular joint dislocation; type III acromio-clavicular joint dislocation; joint dislocation; clavicle hook plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: PEJ-337