Acromio-clavicular Joint Dislocation (Type III)NCT01110304
Acromio-clavicular Dislocation Type III - Conservative Treatment Versus Surgical Hook Plate Treatment
A study testing Conservative treatment - brace and Hook plate by Synthes in people with Acromio-clavicular Joint Dislocation (Type III), run by Hopital de l'Enfant-Jesus at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acromio-clavicular Joint Dislocation (Type III)
- What is being tested?
- Conservative treatment - brace and Hook plate by Synthes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J 1Z4
Stéphane Pelet, MD, PhD, 418-649-0252 ext. 3165, stephane.pelet.ortho@gmail.com
Stéphane Pelet, MD, PhD
About this study
Official title: 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.
- Being tested
- Conservative treatment - brace, Hook plate by Synthes
- Keywords
- acromio-clavicular joint dislocation, type III acromio-clavicular joint dislocation, joint dislocation, clavicle hook plate
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment - braceOther
Also called brace and analgesics
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.
Hook plate by SynthesDevice
Also called hook plate surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Active comparator | Patients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed. Receives: Other: Conservative treatment - brace |
| Surgical treatment | Active comparator | Patients will undergo surgery to treat their AC joint dislocation. Receives: Device: Hook plate by Synthes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (12)
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.
Measured: 3 months after surgery
Rate of secondary surgery
The difference on the reoperation rate between the two groups will be analyzed.
Measured: 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.
Measured: 3 months after surgery
Functional difference
Using the Constant score, the functional difference between the two groups at 6 months will be measured.
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.
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.
Measured: 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).
Measured: 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.
Measured: up to 12 months after surgery
Pain on Visual analog scale (VAS)
Pain is described with the VAS, which range from 1 to 10.
Measured: 6 weeks after surgery
Pain on VAS
Pain is described with the VAS, which range from 1 to 10.
Measured: 3 months after surgery
Pain on VAS
Pain is described with the VAS, which range from 1 to 10.
Measured: 6 months after surgery
Pain on VAS
Pain is described with the VAS, which range from 1 to 10.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startMay 2007
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acromio-clavicular Joint Dislocation (Type III)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital de l'Enfant-Jesus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pelet Stephane, Hopital de l'Enfant-Jesus
- Investigators
- Stéphane Pelet, MD, PhD, Principal investigator, Hôpital Enfant-JésusKarine Sinclair, MD, FRCSC, Principal investigator, Hôpital Enfant-JésusLuc Bédard, MD, FRCSC, Principal investigator, Hôpital Enfant-Jésus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110304
- Sponsor's protocol ID
- PEJ-337
- Status last verified
- Dec 2012
- First submitted
- 21 Apr 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acromio-clavicular Joint Dislocation Type III. Conservative Treatment Compared to Surgical Management With 3.5mm Clavicle Hook Plate. A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01110304
- Acronym / sponsor ID
- PEJ-337
- Keywords
- acromio-clavicular joint dislocation, type III acromio-clavicular joint dislocation, joint dislocation, clavicle hook plate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hopital de l'Enfant-JesusUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Active comparator | Other: Conservative treatment - bracePatients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed. |
| Surgical treatment | Active comparator | Device: Hook plate by SynthesPatients will undergo surgery to treat their AC joint dislocation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative treatment - braceAlso: brace and analgesicsPatients 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 | Conservative treatment |
| Hook plate by SynthesAlso: hook plate surgeryThe 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. | Device | Surgical treatment |
Primary outcome
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.
12 secondary outcomes
Return to professional activities
Time frame: 3 months after surgery
Rate of secondary surgery
Time frame: up to 12 months after surgery
Social impact on SF-36 scale
Time frame: 3 months after surgery
Functional difference
Time frame: 6 months after surgery
Social impact on SF-36 scale
Time frame: 6 months after surgery
Social impact on SF-36 scale
Time frame: 12 months after surgery
Radiologic assessment on the Zanca and axillary views
Time frame: 6 weeks after surgery
Rate of complications
Time frame: up to 12 months after surgery
Pain on Visual analog scale (VAS)
Time frame: 6 weeks after surgery
Pain on VAS
Time frame: 3 months after surgery
Pain on VAS
Time frame: 6 months after surgery
Pain on VAS
Time frame: 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane Pelet, MD, PhD principal investigator
Hôpital Enfant-Jésus
Karine Sinclair, MD, FRCSC principal investigator
Hôpital Enfant-Jésus
Luc Bédard, MD, FRCSC principal investigator
Hôpital Enfant-Jésus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment - brace and Hook plate by Synthes in people with Acromio-clavicular Joint Dislocation (Type III), run by Hopital de l'Enfant-Jesus at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène Côté, Reg. Nurse (418-649-0252 ext. 3165, helco3@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional results of injured shoulder on Constant score (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012; AzTrials last refreshed its copy on 1 Nov 2026.