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Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01274884
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Acromioclavicular Joint Dislocation Procedure: Tightrope fixation

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Series of Acute Acromioclavicular Dislocations Grade III+. Arthroscopic Fixation With Tightrope (R).
Study Start Date : March 2010
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Acromioclavicular joint dislocation
Surgery: Arthroscopic repair using the Tightrope fixation device
Procedure: Tightrope fixation
Arthroscopic repair
Other Name: Tightrope (R) (Arthrex, Naples, Florida)

Outcome Measures

Primary Outcome Measures :
  1. Constant score [ Time Frame: 1 Year ]
    Shoulder outcome score

Secondary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acute acromioclavicular joint dislocation
  • 18 years or older

Exclusion Criteria:

  • Unable to sign informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274884

Asker and Baerum Hospital
Baerum, Rud, Norway, 0407
Sponsors and Collaborators
Sykehuset Asker og Baerum
Study Director: Wender Figved, MD, PhD Baerum Hospital, Vestre Viken, Norway
Principal Investigator: Odd A Lien, MD Baerum Hospital, Vestre Viken, Norway
More Information

Responsible Party: Wender Figved, MD, PhD, Orthopaedic Surgeon, Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier: NCT01274884     History of Changes
Other Study ID Numbers: ACLUX2010
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Wender Figved, Sykehuset Asker og Baerum:

Additional relevant MeSH terms:
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries