Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

November 17, 2014 updated by: Wender Figved, Sykehuset Asker og Baerum

Prospective Series of Acute Acromioclavicular Dislocations Grade III+. Arthroscopic Fixation With Tightrope (R).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Rud
      • Baerum, Rud, Norway, 0407
        • Asker and Baerum Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute acromioclavicular joint dislocation
  • 18 years or older

Exclusion Criteria:

  • Unable to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Acromioclavicular joint dislocation
Surgery: Arthroscopic repair using the Tightrope fixation device
Procedure: Tightrope fixation
Arthroscopic repair
Other Names:
  • Tightrope (R) (Arthrex, Naples, Florida)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant score
Time Frame: 1 Year
Shoulder outcome score
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plain radiographs
Time Frame: 1 Year
1 Year
VAS Pain
Time Frame: 1 Year
Visual analogue acale 1-10
1 Year
VAS Satisfaction
Time Frame: 1 Year
Visual analogue acale 1-10
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Asker og Baerum

Investigators

  • Principal Investigator: Odd A Lien, MD, Baerum Hospital, Vestre Viken, Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (ESTIMATE)

January 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACLUX2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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