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Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01725997
Enrollment
124
Registered
2012-11-14
Start date
2012-11-14
Completion date
2019-06-05
Last updated
2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromioclavicular Joint Dislocation

Keywords

acromioclavicular joint dislocation, ac joint dislocation, acromioclavicular joint separation, hook plate, Rockwood

Brief summary

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.

Interventions

PROCEDUREhook plate

Surgery with hook plate followed by physiotherapy

OTHERPhysiotherapy

Patients will be following a program specific for AC joint dislocations

Sponsors

St Goran's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Constant Scorechange from Baseline in Constant Score at 24 months

Secondary

MeasureTime frame
Disabilities of Arm, Shoulder and Hand function (QuickDASH)change from Baseline in QuickDASH at 24 months

Other

MeasureTime frameDescription
European Quality of Life - 5 dimensions (EQ5D)Change from baseline in EQ-5D at 24 months
Shoulder Pain and Disability Index (SPADI)Change from baseline in SPADI at 24 months
Computed TomographyChange in the position of the AC-joint from baseline to at 24 monthsPosition of the AC-joint
Pain rated with Visual Analogue Scale (VAS)Change from baseline in VAS at 24 months
Radiographs with and without weightChange in the position of the AC-joint from baseline to at 24 monthsPosition of the AC-joint will be measured at standard radiographs and weighted radiographs

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026