Condition category
Musculoskeletal Diseases
Date applied
20/06/2020
Date assigned
06/08/2020
Last edited
06/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Acromioclavicular (shoulder) joint dislocations are common shoulder injuries and are classified according to Rockwood. Type 3 injuries are defined as complete separations with tearing of both ligaments. The current literature is in favour of non-surgical treatment of Rockwood type 3 injuries. However, larger series of high evidence dealing with isolated type 3 injuries are lacking. The aim of this study is to conduct a multicentre, randomized trial comparing non-surgical and surgical treatment. The hypothesis is that surgical treatment in acute ACJ dislocations type 3 outperforms non-surgical treatment in terms of functional outcome after a follow-up period of 2 years.

Who can participate?
Patients aged between 18 and 65 years suffering from an acute (within 3 weeks after the trauma) acromioclavicular joint dislocation Rockwood type 3.

What does the study involve?
The study involves regular radiological and clinical follow up evaluation at baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months. Two treatment modalities are compared after randomized allocation of the study participants. The functional outcome of non-surgical and surgical treatment are evaluated using specific shoulder scores and the pain level is recorded at all timepoints. Radiological parameters are measured including the coracoclavicular distance and posttraumatic osteoarthritis or heterotopic ossifications.

What are the possible benefits and risks of participating?
All patients undergo standardized state of the art medical treatment when participating. Since the best treatment option for acute Rockwood type 3 injuries is still not determined, there is no benefit or risk of participating. After detailed information about kind of injury and possible treatment options patients are included after obtaining written informed consent.

Where is the study run from?
The study is allocated in 4 study centers. Three of them are located in Germany, one in Austria.

When is the study starting and how long is it expected to run for?
July 2010 to March 2018

Who is funding the study?
There is no outside funding of the study.

Who is the main contact?
Mark Tauber, MD
tauber@atos.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mark Tauber

ORCID ID

Contact details

ATOS Clinic Munich
Effnerstrasse 38
Munich
81925
Germany
+49 89 204000210
tauber@atos.de

Type

Public

Additional contact

Prof Mark Tauber

ORCID ID

Contact details

ATOS Clinic Munich
Effenrstrasse 38
Munich
81925
Germany
+49 89 204000210
tauber@atos.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

No difference between surgical and non-surgical treatment of acute acromioclavicular Rockwood type III injuries - a prospective, multicentric randomized trial

Acronym

Study hypothesis

Surgical treatment in acute acromioclavicular joint (ACJ) dislocations Rockwood type III outperforms non-surgical treatment in terms of functional outcome after a follow-up (FU) period of 2 years.

Ethics approval

Approved 12/09/2010, Salzburg Ethics Committee (Ethical Committe for Salzburg County, Michael-Pacher-Strasse 36 (EG, Zi.48), 5020 Salzburg, Austria; no telephone number provided; ethikkommission@salzburg.gv.at), ref: 1277

Study design

Multicenter interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files (in German)

Condition

Acute acromioclavicular joint dislocations Rockwood type 3

Intervention

Surgical versus non-surgical treatment of acute acromioclavicular joint dislocations Rockwood type 3 will be compared.
Non-surgical treatment includes adequate pain management using non-steroidal antirheumatics for several days, accompanied by local ice therapy and immobilization of the injured shoulder using a simple sling. Duration of immobilization is based on the patient’s pain level and lasts usually between 10 to 14 days. Physical rehabilitation measures are initiated under a physiotherapist’s guidance and continued until free ROM is achieved.
Surgical treatment includes 4 different surgical techniques, one for each study center. These are the hook plate (center 1), the Tight Rope device (Arthrex, Naples, FL, USA) implanted arthrscopically in a double fashion (center 2), in a single fashion (center 3) and mini-open in a double fashion (center 4).
The postoperative protocol is the same for all techniques including pain management, local ice therapy, and immobilization for 6 weeks in a simple sling. During this period only passive motion and exercises until 90° of glenohumeral abduction are allowed. Actively assisted shoulder motion in all planes follows for the next 6 weeks starting with shoulder sports after 4 months.

After obtaining the patients’ written consent 1:1 allocation to either surgical or non-surgical treatment was performed by the treating surgeon at each center based on a pre-specified list generated by the principal investigator using a web-based internet randomizer [www.randomize.net].

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

The functional outcome using the Constant score is measured at baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Secondary outcome measures

Recovery measured using the following measures:
1. Pain measured using a numeric rating scale at baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
2. The Acromioclavicular Joint Injury Score measured at baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
3. The Taft score measured at baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
4. The American Shoulder and Elbow Surgeon's score measured at baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months
5. The coracoclavicular distance (in milimeters) measured at baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Overall trial start date

01/07/2010

Overall trial end date

31/03/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Presence of an acute (within 3 weeks after trauma) ACJ injury
2. ACJ dislocation type III according to the classification of Rockwood defined by an increase of the coracoclavicular distance of 25-100% compared to the contralateral side on a panorama stress-view with 10kg of load on the hanging arm
3. Aged between 18 and 65 years
4. Written informed consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Patient’s request for reconstruction out of cosmetic purposes
2. Pre-existing shoulder- or ACJ-related pathologies of the affected or contralateral shoulder
3. Acute or chronic infections of the involved joint
4. Neurological or musculoskeletal diseases affecting the shoulder
5. Inadequate compliance
6. Inability to participate in the regular FUs
7. Abuse of drugs or alcohol
8. Worker’s compensation claim

Recruitment start date

01/01/2011

Recruitment end date

31/03/2016

Locations

Countries of recruitment

Austria, Germany

Trial participating centre

ATOS clinic Munich
Effnerstrasse 38
Munich
81925
Germany

Trial participating centre

University Clinic Charitè
Department of Orthopaedics and Trauma Surgery Charitèplatz 1
Berlin
10117
Germany

Trial participating centre

University clinic Mannheim
Department of Orthopaedics and Trauma Surgery Theodor-Kutzer-Ufer 1 - 3
Mannheim
68167
Germany

Trial participating centre

University clinic Salzburg
Department of Orthopaedics and Trauma Surgery Muellner Hauptstrasse 48
Salzburg
5020
Austria

Sponsor information

Organisation

Paracelsus Medical University

Sponsor details

Strubergasse 20
Salzburg
5020
Austria
+43 662 2420-80205
claudia.melchart@pmu.ac.at

Sponsor type

University/education

Website

http://www.pmu.ac.at/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository.

Intention to publish date

01/08/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/08/2020: Internal review. 06/08/2020: The participant information sheet has been uploaded. 13/07/2020: Trial’s existence confirmed by Land Salzburg ethics board.