Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014