Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

NCT01725997 | Completed

• 1 other identifier: AC-lux
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromioclavicular Joint Dislocation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Constant Score

  change from Baseline in Constant Score at 24 months

Secondary Outcomes (1)

• Disabilities of Arm, Shoulder and Hand function (QuickDASH)

  change from Baseline in QuickDASH at 24 months

Other Outcomes (5)

• Shoulder Pain and Disability Index (SPADI)

  Change from baseline in SPADI at 24 months

• Radiographs with and without weight

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

• European Quality of Life - 5 dimensions (EQ5D)

  Change from baseline in EQ-5D at 24 months

Study Arms (2)

Operative treatment

ACTIVE COMPARATOR

Operative treatment with hook plate.

Procedure: hook plate

Conservative treatment

ACTIVE COMPARATOR

Physiotherapy

Other: Physiotherapy

Interventions

hook plate PROCEDURE

Surgery with hook plate followed by physiotherapy

Also known as: hook plate by Synthes

Operative treatment

Physiotherapy OTHER

Patients will be following a program specific for AC joint dislocations

Conservative treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Goran's Hospital: lead

Study Sites (1)

Capio St Gorans Hospital AB

Stockholm, SE-11281, Sweden

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Helena Boström Windhamre

  Capio St Gorans hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 14, 2012
• Study Start: November 14, 2012
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

SE (1)