Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

Not Applicable

Completed

• Conditions: Acromioclavicular Joint Dislocation
• Interventions: Procedure: Tightrope fixation

• Registration Number: NCT01274884
• Lead Sponsor: Sykehuset Asker og Baerum

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.

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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Acute acromioclavicular joint dislocation
• 18 years or older

Exclusion Criteria

• Unable to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acromioclavicular joint dislocation	Tightrope fixation	Surgery: Arthroscopic repair using the Tightrope fixation device

Primary Outcome Measures

Name	Time	Method
Constant score	1 Year	Shoulder outcome score

Secondary Outcome Measures

Name	Time	Method
Plain radiographs	1 Year
VAS Pain	1 Year	Visual analogue acale 1-10
VAS Satisfaction	1 Year	Visual analogue acale 1-10

Trial Locations

Locations (1)

Asker and Baerum Hospital; 🇳🇴 Baerum, Rud, Norway