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NCT01274884 Clinical Trial

Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

Acromioclavicular Joint Dislocation Clinical Trial

Official title:
Prospective Series of Acute Acromioclavicular Dislocations Grade III+. Arthroscopic Fixation With Tightrope (R).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01274884
Other study ID # ACLUX2010
Secondary ID
Status Completed
Phase N/A
First received January 11, 2011
Last updated November 17, 2014
Start date March 2010
Est. completion date July 2013

Study information
Verified date November 2014
Source Sykehuset Asker og Baerum
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Institute of Public HealthNorway: Directorate of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Acute acromioclavicular joint dislocation

- 18 years or older

Exclusion Criteria:

- Unable to sign informed consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Tightrope fixation
Arthroscopic repair

Locations
Country Name City State
Norway Asker and Baerum Hospital Baerum Rud

Sponsors (1)
Lead Sponsor Collaborator
Sykehuset Asker og Baerum

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Constant score Shoulder outcome score 1 Year No
Secondary Plain radiographs 1 Year No
Secondary VAS Pain Visual analogue acale 1-10 1 Year No
Secondary VAS Satisfaction Visual analogue acale 1-10 1 Year No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05976256 - Kinesiotaping in Trauma N/A
Completed NCT03261778 - Comparison of Two Types of Braces in the Treatment of Rockwood Type III AC-dislocations N/A
Completed NCT01725997 - Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation N/A
Recruiting NCT03060564 - Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft N/A
Withdrawn NCT02195219 - Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations N/A
Not yet recruiting NCT06019260 - Open Versus Arthroscopic Assisted Treatment of Acute Acromioclavicular Joint Disruption Using Suture Button Device
Recruiting NCT05501509 - Comparison of Coracoclavicular Fixation With Versus Without Acromioclavicular Stabilization for Repair of Acute Acromioclavicular Joint Dislocations: A Randomized Controlled Clinical Trial N/A
Recruiting NCT02677441 - Conservative or Surgical Management of Rockwood Type III to V Acromioclavicular Dislocations N/A
Completed NCT03727178 - Acute Acromioclavicular Dislocation: Epidemiology, Natural History and Analysis of Prognostic Factors
Recruiting NCT05844098 - Arthroscopic Assisted CC Stabilization Alone VS Additional K-wire Fixation for Acute Acromioclavicular Joint Injury N/A