Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

January 26, 2020 updated by: Helena Boström Windhamre, St Goran's Hospital

Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation Rockwood Grade III and V - a Prospective Randomized Study

The study aims to answer if surgery with hook plate for acute dislocation of the acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to conservative treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-11281
        • Capio St Gorans Hospital AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AC joint dislocation grade III according to Rockwood with at least half a clavicular bone width above the acromion or grade V according to Rockwood
  • men and women 18-65 years and able to work
  • understand spoken and/or written Swedish or English language
  • be able to start treatment within 3 weeks from trauma
  • consent form signed

Exclusion Criteria:

  • earlier injury to, or surgery of either of the shoulders
  • simultaneous fracture of the clavicle or acromion
  • associates neurovascular injury
  • severe osteoporosis
  • open dislocation
  • open growth plate of the acromion
  • local skin damage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Operative treatment
Operative treatment with hook plate.
Procedure: hook plate
Surgery with hook plate followed by physiotherapy
Other Names:
  • hook plate by Synthes
Active Comparator: Conservative treatment
Physiotherapy
Other: Physiotherapy
Patients will be following a program specific for AC joint dislocations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Constant Score
Time Frame: change from Baseline in Constant Score at 24 months
change from Baseline in Constant Score at 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disabilities of Arm, Shoulder and Hand function (QuickDASH)
Time Frame: change from Baseline in QuickDASH at 24 months
change from Baseline in QuickDASH at 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: Change from baseline in SPADI at 24 months
Change from baseline in SPADI at 24 months
Radiographs with and without weight
Time Frame: Change in the position of the AC-joint from baseline to at 24 months
Position of the AC-joint will be measured at standard radiographs and weighted radiographs
Change in the position of the AC-joint from baseline to at 24 months
European Quality of Life - 5 dimensions (EQ5D)
Time Frame: Change from baseline in EQ-5D at 24 months
Change from baseline in EQ-5D at 24 months
Pain rated with Visual Analogue Scale (VAS)
Time Frame: Change from baseline in VAS at 24 months
Change from baseline in VAS at 24 months
Computed Tomography
Time Frame: Change in the position of the AC-joint from baseline to at 24 months
Position of the AC-joint
Change in the position of the AC-joint from baseline to at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Goran's Hospital

Investigators

  • Principal Investigator: Helena Boström Windhamre, Capio St Görans Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2012

Primary Completion (Actual)

June 5, 2019

Study Completion (Actual)

June 5, 2019

Study Registration Dates

First Submitted

October 31, 2012

First Submitted That Met QC Criteria

November 8, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 26, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-lux

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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