Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014