Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

NCT ID: NCT01725997

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-14

Study Completion Date

2019-06-05

Brief Summary

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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.

Detailed Description

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Conditions

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Acromioclavicular Joint Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Operative treatment

Operative treatment with hook plate.

Group Type ACTIVE_COMPARATOR

hook plate

Intervention Type PROCEDURE

Surgery with hook plate followed by physiotherapy

Conservative treatment

Physiotherapy

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type OTHER

Patients will be following a program specific for AC joint dislocations

Interventions

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hook plate

Surgery with hook plate followed by physiotherapy

Intervention Type PROCEDURE

Physiotherapy

Patients will be following a program specific for AC joint dislocations

Intervention Type OTHER

Other Intervention Names

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hook plate by Synthes

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Goran's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Helena Boström Windhamre

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helena Boström Windhamre

Role: PRINCIPAL_INVESTIGATOR

Capio St Gorans hospital

Locations

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Capio St Gorans Hospital AB

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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AC-lux

Identifier Type: -

Identifier Source: org_study_id

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