Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

Acromioclavicular Joint Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725997
• Other study ID #: AC-lux
• Status: Completed
• Phase: N/A
• Start date: November 14, 2012
• Est. completion date: June 5, 2019

Study information

• Verified date: January 2020
• Source: St Goran's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromioclavicular Joint Dislocation

Intervention

Procedure:
• hook plate
Surgery with hook plate followed by physiotherapy

Other:
• Physiotherapy
Patients will be following a program specific for AC joint dislocations

Locations

Country	Name	City	State
Sweden	Capio St Gorans Hospital AB	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
St Goran's Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Shoulder Pain and Disability Index (SPADI)		Change from baseline in SPADI at 24 months
Other	Radiographs with and without weight	Position of the AC-joint will be measured at standard radiographs and weighted radiographs	Change in the position of the AC-joint from baseline to at 24 months
Other	European Quality of Life - 5 dimensions (EQ5D)		Change from baseline in EQ-5D at 24 months
Other	Pain rated with Visual Analogue Scale (VAS)		Change from baseline in VAS at 24 months
Other	Computed Tomography	Position of the AC-joint	Change in the position of the AC-joint from baseline to at 24 months
Primary	Constant Score		change from Baseline in Constant Score at 24 months
Secondary	Disabilities of Arm, Shoulder and Hand function (QuickDASH)		change from Baseline in QuickDASH at 24 months