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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
History of Changes
  Purpose

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 Intervention
Acromioclavicular Joint Dislocation
 Procedure: Tightrope fixation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Series of Acute Acromioclavicular Dislocations Grade III+. Arthroscopic Fixation With Tightrope (R).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sykehuset Asker og Baerum:

Primary Outcome Measures:
  • Constant score [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Shoulder outcome score


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: March 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute acromioclavicular joint dislocation
  • 18 years or older

Exclusion Criteria:

  • Unable to sign informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274884

Contacts
Contact: Wender Figved, MD, PhD +4767809400 wender@mac.com
Contact: Odd A Lien, MD +4767809400 odd.arve.lien@vestreviken.no

Locations
Norway
Asker and Baerum Hospital Recruiting
Baerum, Rud, Norway, 0407
Contact: Wender Figved, MD     +4767809400     wender@mac.com    
Principal Investigator: Odd A Lien, MD            
Sponsors and Collaborators
Sykehuset Asker og Baerum
Investigators
Study Director: Wender Figved, MD, PhD Baerum Hospital, Vestre Viken, Norway
Principal Investigator: Odd A Lien, MD Baerum Hospital, Vestre Viken, Norway
  More Information

No publications provided

Responsible Party: Wender Figved, MD, PhD, Orthopaedic Surgeon, Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier: NCT01274884     History of Changes
Other Study ID Numbers: ACLUX2010
Study First Received: January 11, 2011
Last Updated: February 8, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Institute of Public Health
Norway: Directorate of Health

Keywords provided by Sykehuset Asker og Baerum:
Acromioclavicular
Injury
Dislocation
Surgery

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on June 18, 2013