Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

This study is currently recruiting participants.
Verified February 2013 by Sykehuset Asker og Baerum
Sponsor:
Information provided by (Responsible Party):
Wender Figved, Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier:
NCT01274884
First received: January 11, 2011
Last updated: February 8, 2013
Last verified: February 2013

January 11, 2011
February 8, 2013
March 2010
June 2013   (final data collection date for primary outcome measure)
Constant score [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Shoulder outcome score
Same as current
Complete list of historical versions of study NCT01274884 on ClinicalTrials.gov Archive Site
  • Plain radiographs [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • VAS Pain [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Visual analogue acale 1-10
  • VAS Satisfaction [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Visual analogue acale 1-10
Same as current
Not Provided
Not Provided
 
Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromioclavicular Joint Dislocation
Procedure: Tightrope fixation
Arthroscopic repair
Other Name: Tightrope (R) (Arthrex, Naples, Florida)
Active Comparator: Acromioclavicular joint dislocation
Surgery: Arthroscopic repair using the Tightrope fixation device
Intervention: Procedure: Tightrope fixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
July 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acute acromioclavicular joint dislocation
  • 18 years or older

Exclusion Criteria:

  • Unable to sign informed consent
Both
18 Years and older
No
Contact: Wender Figved, MD, PhD +4767809400 wender@mac.com
Contact: Odd A Lien, MD +4767809400 odd.arve.lien@vestreviken.no
Norway
 
NCT01274884
ACLUX2010
No
Wender Figved, Sykehuset Asker og Baerum
Sykehuset Asker og Baerum
Not Provided
Study Director: Wender Figved, MD, PhD Baerum Hospital, Vestre Viken, Norway
Principal Investigator: Odd A Lien, MD Baerum Hospital, Vestre Viken, Norway
Sykehuset Asker og Baerum
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP