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Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Helena Boström Windhamre, St Goran's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725997
First Posted: November 14, 2012
Last Update Posted: November 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Helena Boström Windhamre, St Goran's Hospital
  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 (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 Helena Boström Windhamre, St Goran's Hospital:

Primary Outcome Measures:
  • Constant Score [ Time Frame: change from Baseline in Constant Score at 24 months ]

Secondary Outcome Measures:
  • Disabilities of Arm, Shoulder and Hand function (QuickDASH) [ Time Frame: change from Baseline in QuickDASH at 24 months ]

Other Outcome Measures:
  • Shoulder Pain and Disability Index (SPADI) [ Time Frame: 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

  • European Quality of Life - 5 dimensions (EQ5D) [ Time Frame: 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 ]
  • Computed Tomography [ Time Frame: Change in the position of the AC-joint from baseline to at 24 months ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Helena Boström Windhamre, MD, St Goran's Hospital
ClinicalTrials.gov Identifier: NCT01725997     History of Changes
Other Study ID Numbers: AC-lux
First Submitted: October 31, 2012
First Posted: November 14, 2012
Last Update Posted: November 16, 2012
Last Verified: November 2012

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

Additional relevant MeSH terms:
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries