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OpenTrials
Completed

NCT Number: NCT01274884

Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asker and Baerum Hospital

Baerum, Rud, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute acromioclavicular joint dislocation
  • 18 years or older

Exclusion criteria

  • Unable to sign informed consent

Treatment and study plan

Tightrope fixation

Procedure

Arthroscopic repair

Other names: Tightrope (R) (Arthrex, Naples, Florida)

Primary outcomes

  1. Constant score

    Time frame: 1 Year

    Shoulder outcome score

Secondary outcomes

  1. Plain radiographs

    Time frame: 1 Year

  2. VAS Pain

    Time frame: 1 Year

    Visual analogue acale 1-10

  3. VAS Satisfaction

    Time frame: 1 Year

    Visual analogue acale 1-10

Sponsors and collaborators

Lead sponsor

Sykehuset Asker og Baerum

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 12, 2011
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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