Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

This study is currently recruiting participants.
Verified November 2012 by St Goran's Hospital
Sponsor:
Information provided by (Responsible Party):
Helena Boström Windhamre, St Goran's Hospital
ClinicalTrials.gov Identifier:
NCT01725997
First received: October 31, 2012
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Acromioclavicular Joint Dislocation
Procedure: hook plate
Other: Physiotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation Rockwood Grade III and V - a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by St Goran's Hospital:

Primary Outcome Measures:
  • Constant Score [ Time Frame: change from Baseline in Constant Score at 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disabilities of Arm, Shoulder and Hand function (QuickDASH) [ Time Frame: change from Baseline in QuickDASH at 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Shoulder Pain and Disability Index (SPADI) [ Time Frame: Change from baseline in SPADI at 24 months ] [ Designated as safety issue: No ]
  • Radiographs with and without weight [ Time Frame: Change in the position of the AC-joint from baseline to at 24 months ] [ Designated as safety issue: No ]
    Position of the AC-joint will be measured at standard radiographs and weighted radiographs

  • European Quality of Life - 5 dimensions (EQ5D) [ Time Frame: Change from baseline in EQ-5D at 24 months ] [ Designated as safety issue: No ]
  • Pain rated with Visual Analogue Scale (VAS) [ Time Frame: Change from baseline in VAS at 24 months ] [ Designated as safety issue: No ]
  • Computed Tomography [ Time Frame: Change in the position of the AC-joint from baseline to at 24 months ] [ Designated as safety issue: No ]
    Position of the AC-joint


Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Operative treatment
Operative treatment with hook plate.
Procedure: hook plate
Surgery with hook plate followed by physiotherapy
Other Name: hook plate by Synthes
Active Comparator: Conservative treatment
Physiotherapy
Other: Physiotherapy
Patients will be following a program specific for AC joint dislocations

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725997

Contacts
Contact: Helena Boström Windhamre, MD +46858701377 helena.bostrom@capio.se
Contact: Anders Ekelund, MD, associate professor

Locations
Sweden
Capio St Gorans Hospital AB Recruiting
Stockholm, Sweden, SE-11281
Contact: Helena Boström Windhamre, MD    +46858701377    helena.bostrom@capio.se   
Principal Investigator: Helena Boström Windhamre, MD         
Sponsors and Collaborators
St Goran's Hospital
Investigators
Principal Investigator: Helena Boström Windhamre, MD Capio St Gorans Hospital
  More Information

No publications provided

Responsible Party: Helena Boström Windhamre, MD, St Goran's Hospital
ClinicalTrials.gov Identifier: NCT01725997     History of Changes
Other Study ID Numbers: AC-lux
Study First Received: October 31, 2012
Last Updated: November 15, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by St Goran's Hospital:
acromioclavicular joint dislocation
ac joint dislocation
acromioclavicular joint separation
hook plate
Rockwood

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014