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Completed

NCT Number: NCT01725997

Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

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.

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Key information

Conditions

Acromioclavicular Joint Dislocation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capio St Gorans Hospital AB

Stockholm, SE-11281, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hook plate

Procedure

Surgery with hook plate followed by physiotherapy

Other names: hook plate by Synthes

Physiotherapy

Other

Patients will be following a program specific for AC joint dislocations

Primary outcomes

  1. Constant Score

    Time frame: change from Baseline in Constant Score at 24 months

Secondary outcomes

  1. Disabilities of Arm, Shoulder and Hand function (QuickDASH)

    Time frame: change from Baseline in QuickDASH at 24 months

Other outcomes

  1. Shoulder Pain and Disability Index (SPADI)

    Time frame: Change from baseline in SPADI at 24 months

  2. 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

  3. European Quality of Life - 5 dimensions (EQ5D)

    Time frame: Change from baseline in EQ-5D at 24 months

  4. Pain rated with Visual Analogue Scale (VAS)

    Time frame: Change from baseline in VAS at 24 months

  5. Computed Tomography

    Time frame: Change in the position of the AC-joint from baseline to at 24 months

    Position of the AC-joint

Sponsors and collaborators

Lead sponsor

St Goran's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2012
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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