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Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

NCT ID: NCT01274884

Last Updated: 2014-11-19

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-07-31

Brief Summary

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Several surgical techniques are used for the treatment of acute acromioclavicular joint dislocations. The investigators investigate a new method using arthroscopic repair using the Tightrope fixation device.

Detailed Description

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The Tightrope consists of a suspension system with a strong suture thread intertwined between an oval button and a round button, which is inserted through drilling holes in the clavicula and the coracoid. The investigators want to prospectively evaluate the results in a series of 25 patients.

Conditions

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Acromioclavicular Joint Dislocation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acromioclavicular joint dislocation

Surgery: Arthroscopic repair using the Tightrope fixation device

Group Type ACTIVE_COMPARATOR

Tightrope fixation

Intervention Type PROCEDURE

Arthroscopic repair

Interventions

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Tightrope fixation

Arthroscopic repair

Intervention Type PROCEDURE

Other Intervention Names

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Tightrope (R) (Arthrex, Naples, Florida)

Eligibility Criteria

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Inclusion Criteria

* Acute acromioclavicular joint dislocation
* 18 years or older

Exclusion Criteria

* Unable to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset Asker og Baerum

OTHER

Sponsor Role lead

Responsible Party

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Wender Figved

MD, PhD, Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wender Figved, MD, PhD

Role: STUDY_DIRECTOR

Baerum Hospital, Vestre Viken, Norway

Odd A Lien, MD

Role: PRINCIPAL_INVESTIGATOR

Baerum Hospital, Vestre Viken, Norway

Locations

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Asker and Baerum Hospital

Baerum, Rud, Norway

Site Status

Countries

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Norway

Other Identifiers

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ACLUX2010

Identifier Type: -

Identifier Source: org_study_id