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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Hopital de l'Enfant-Jesus
Sponsor:
Information provided by (Responsible Party):
Pelet Stephane, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier:
NCT01110304
First received: April 21, 2010
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Acromio-clavicular Joint Dislocation (Type III)
Other: Conservative treatment - brace
Device: Hook plate by Synthes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acromio-clavicular Joint Dislocation Type III. Conservative Treatment Compared to Surgical Management With 3.5mm Clavicle Hook Plate. A Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Hopital de l'Enfant-Jesus:

Primary Outcome Measures:
  • Functional results of injured shoulder on Constant score [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Return to professional activities [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    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.

  • Rate of secondary surgery [ Time Frame: up to 12 months after surgery ] [ Designated as safety issue: No ]
    The difference on the reoperation rate between the two groups will be analyzed.

  • Social impact on SF-36 scale [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    The social impact of both treatments will be measured with the SF-36 score.

  • Functional difference [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Using the Constant score, the functional difference between the two groups at 6 months will be measured.

  • Social impact on SF-36 scale [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    The social impact of both treatments will be measured with the SF-36 score.

  • Social impact on SF-36 scale [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    The social impact of both treatments will be measured with the SF-36 score.

  • Radiologic assessment on the Zanca and axillary views [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]

    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).


  • Rate of complications [ Time Frame: up to 12 months after surgery ] [ Designated as safety issue: No ]
    The rate of complications both general and orthopaedic will be described in the in percentage of the number of patients per group.

  • Pain on Visual analog scale (VAS) [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    Pain is described with the VAS, which range from 1 to 10.

  • Pain on VAS [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    Pain is described with the VAS, which range from 1 to 10.

  • Pain on VAS [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Pain is described with the VAS, which range from 1 to 10.

  • Pain on VAS [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]
    Pain is described with the VAS, which range from 1 to 10.


Estimated Enrollment: 56
Study Start Date: May 2007
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: hook plate surgery

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110304

Contacts
Contact: Hélène Côté, Reg. Nurse 418-649-0252 ext 3165 helco3@hotmail.com
Contact: Stéphane Pelet, MD, PhD 418-649-0252 ext 3165 stephane.pelet.ortho@gmail.com

Locations
Canada, Quebec
CHA-Pavillon Enfant-Jésus Recruiting
Québec, Quebec, Canada, G1J 1Z4
Contact: Stéphane Pelet, MD, PhD    418-649-0252 ext 3165    stephane.pelet.ortho@gmail.com   
Principal Investigator: Stéphane Pelet, MD, PhD         
Sponsors and Collaborators
Hopital de l'Enfant-Jesus
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Pelet Stephane, Dr Stephane Pelet MD, PhD Orthopedic surgeon, Hopital de l'Enfant-Jesus
ClinicalTrials.gov Identifier: NCT01110304     History of Changes
Other Study ID Numbers: PEJ-337
Study First Received: April 21, 2010
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Hopital de l'Enfant-Jesus:
acromio-clavicular joint dislocation
type III acromio-clavicular joint dislocation
joint dislocation
clavicle hook plate

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries
Analgesics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014