Condition category
Injury, Occupational Diseases, Poisoning
Date applied
15/06/2013
Date assigned
07/11/2013
Last edited
07/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Injuries to the shoulder joint are common and often result in long-term pain, reduced function and an unsightly deformity over the shoulder. It is widely accepted that sprains and minor disclocations of the shoulder joint are best treated conservatively, but there is growing debate about the most appropriate treatment of complete dislocations. We wish to compare the results of non-operative and operative treatment for complete shoulder joint dislocations to guide future treatment.

Who can participate?
Men and women aged 16-35 years who have sustained a complete dislocation of the shoulder joint within the last two weeks may be invited to participate in the study.

What does the study involve?
Patients who decide to take part in the study will be randomly allocated to one of two groups. Those allocated to the non-operative group will be treated with an initial three-week period of immobilisation in a collar and cuff followed by physiotherapy. Participants allocated to the operative treatment group will undergo surgery to stabilise the joint within two weeks of injury. The procedure will be done through the open or keyhole method and will involve reconstruction of the injured ligaments around the injured joint. After surgery, patients will then be treated with immobilisation in a collar and cuff for three weeks followed by physiotherapy. All patients will be seen at three weeks, six weeks, three months, six months and one year, when they may be asked to complete a questionnaire and will undergo an examination. X-rays are also routinely taken during return visits.

What are the possible benefits and risks of participating?
The major benefit of having surgery is that they will have a stable shoulder joint after the surgery, with less of a visible bump. This may allow an earlier return to work and sports. All the surgical procedures are performed under general anaesthetic. Although anaesthesia is extremely safe with modern techniques, there are still very small risks involved. Some patients experience nausea, vomiting and/or dizziness. These are reduced with modern drugs. It is important that participants tell the research team about any medical problems. For those that are allocated to have an operation, the main risk is that the surgery fails to stabilise the injured joint and further instability is experienced (5% risk). There is a small chance of developing wound infection. This may require treatment with antibiotics. There is also a small risk of damage to the adjacent nerves and vessels in the shoulder.

Where is the study run from?
The study is being run from multiple orthopaedic centres who are experienced in both the management of these injuries and conducting studies of this kind including:
1. The Royal Infirmary of Edinburgh, UK (primary centre)
2. Glasgow Victoria Hospital, Glasgow, UK
3. Glasgow Western Infirmary, UK
4. Glasgow Royal Infirmary, UK

When is study starting and how long is it expected to run for?
The study began recruiting patients in February 2011 and will continue for five years.

Who is funding the study?
The study is funded by Arthrex, USA.

Who is the main contact?
Mr C M Robinson
+44 (0)131 536 1000
c.mike.robinson@ed.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Michael Robinson

ORCID ID

Contact details

Department of Trauma and Orthopaedics
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH164SA
United Kingdom
+44 (0)131 242 3407
c.mike.robinson@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10/S1101/55

Study information

Scientific title

A multicentre prospective randomised controlled trial to compare the results of AcromioClavicular Open Reduction versus Nonoperative treatment for the management of acute grade III and IV acromioclavicular joint disruption

Acronym

ACORN

Study hypothesis

Operative management will not improve the functional outcome over non-operative management for acute grade III and IV acromioclavicular joint disruption.

Ethics approval

Lothian Research Ethics Committee,10/S1101/55

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Orthopaedic Trauma

Intervention

A total of 80 participants will be randomised using the closed envelope technique into a control (non-operative management) group or treatment (operative management) group each containing 40 participants. All patients will be initially evaluated with a complete history and physical examination. Information regarding the mode of injury and timing of initial symptoms, any previous surgical procedures performed, and current type, level and frequency of symptoms including pain, instability and level of function will be specifically sought in addition to routine demographic details. Preoperative imaging including standardised plain film evaluation of the affected shoulder will be taken.

Control group – non-operative management
Following randomisation into the control group, participants will be treated with immobilisation in a collar and cuff for three weeks. Patients will return for clinical assessment 3 weeks following initial injury and will then begin a course of physiotherapy. Further clinical assessments will be scheduled at 6 weeks, 3 months, 6 months and 12 months.

Treatment group – operative treatment
Following randomisation into the treatment group, participants will be undergo open stabilisation with coracoclavicular ligamentous substitution within two weeks of the initial injury.

Open stabilisation with coracoclavicular ligamentous substitution
The following steps will performed through an open approach. The disrupted acromioclavicular joint will be visualized and reduced with no excision of lateral clavicle or acrion. Repair of existing acromioclavicular and coracoclavicular ligaments will be performed. Stabilization will be achieved using the AC-Tightrope Technique, with the Tightrope spanning between the coracoid and lateral clavicle. In all centres, the operative procedure will be carried out by a specialist shoulder surgeon. The potential risks of operative stabilisation will be explained by the operating surgeon. These include risk of recurrent instability (5%), infection (1%) and death under general anaesthetic (1 in 200,000).

Postoperative protocol and follow-up
Patients will be immobilised for 3 weeks postoperatively in a collar and cuff. These patients will be routinely discharged on day 1 postoperatively. Patients will return for clinical assessment 3 weeks following initial injury and will then begin a course of physiotherapy. Active strengthening will commence at 6 weeks. Further clinical assessments will be scheduled at 6 weeks, 3 months, 6 months and 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Functional assessment with use of the short-form health survey (SF-12), Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and Oxford score will be carried out for all patients preoperatively, at 6 weeks and at 12 months porstoperatively. In addition SF-12 and DASH scores will be assessed at 3 and 6 months.

Secondary outcome measures

1. Shoulder ROM will be assessed at 6 months and 12 months postoperatively. The contralateral shoulder will be assessed for comparison
2. Any complications occurring in patients in either group will be documented at the time of procedure and throughout follow-up
3. Radiographic evidence of recurrent dislocation

Overall trial start date

01/02/2011

Overall trial end date

01/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Grade III or IV acromioclavicular joint disruption
2. Acute injury (within last 2 weeks)
3. Age 16-35 years inclusive

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Grade I or II acromioclavicular joint disruptions
2. Patients who are not local residents and unable to attend for follow-up
3. Coexisting clavicle or proximal humeral fractures
4. Multiple medical co-morbidities

Recruitment start date

01/02/2011

Recruitment end date

01/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Trauma and Orthopaedics
Edinburgh
EH164SA
United Kingdom

Sponsor information

Organisation

Royal Infirmary of Edinburgh (UK)

Sponsor details

c/o Karen Maitland
NHS Lothian Research and Development
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Arthrex (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes