Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment
|ClinicalTrials.gov Identifier: NCT01110304|
Recruitment Status : Unknown
Verified December 2012 by Pelet Stephane, Hopital de l'Enfant-Jesus.
Recruitment status was: Recruiting
First Posted : April 26, 2010
Last Update Posted : December 20, 2012
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 or disease||Intervention/treatment|
|Acromio-clavicular Joint Dislocation (Type III)||Other: Conservative treatment - brace Device: Hook plate by Synthes|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Acromio-clavicular Joint Dislocation Type III. Conservative Treatment Compared to Surgical Management With 3.5mm Clavicle Hook Plate. A Prospective Randomized Study|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||February 2015|
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
- Functional results of injured shoulder on Constant score [ Time Frame: 3 months after surgery ]
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.
- Return to professional activities [ Time Frame: 3 months after surgery ]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 ]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 ]The social impact of both treatments will be measured with the SF-36 score.
- Functional difference [ Time Frame: 6 months after surgery ]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 ]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 ]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 ]
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 ]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 ]Pain is described with the VAS, which range from 1 to 10.
- Pain on VAS [ Time Frame: 3 months after surgery ]Pain is described with the VAS, which range from 1 to 10.
- Pain on VAS [ Time Frame: 6 months after surgery ]Pain is described with the VAS, which range from 1 to 10.
- Pain on VAS [ Time Frame: 12 months after surgery ]Pain is described with the VAS, which range from 1 to 10.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110304
|Contact: Hélène Côté, Reg. Nurse||418-649-0252 ext firstname.lastname@example.org|
|Contact: Stéphane Pelet, MD, PhD||418-649-0252 ext email@example.com|
|Québec, Quebec, Canada, G1J 1Z4|
|Contact: Stéphane Pelet, MD, PhD 418-649-0252 ext 3165 firstname.lastname@example.org|
|Principal Investigator: Stéphane Pelet, MD, PhD|
|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|