Tightrope Fixation of Acromioclavicular Joint Dislocation... | NCT01274884

Studies
Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series

NCT01274884

Sponsor

Sykehuset Asker og Baerum

Status

Completed

Last Update Posted

Nov 19, 2014Estimated

Enrollment

25Actual

Phase

Not Applicable

Conditions

Acromioclavicular Joint Dislocation

Interventions

Tightrope fixation

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jan 11, 2011

First Submission Date that Met QC Criteria

Jan 11, 2011

First Posted Date

Jan 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acromioclavicular joint dislocation	Active Comparator	Surgery: Arthroscopic repair using the Tightrope fixation device	Procedure: Tightrope fixation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tightrope fixation	Procedure	Arthroscopic repair	Acromioclavicular joint dislocation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Constant score	Shoulder outcome score	1 Year

Secondary Outcomes

Measure	Description	Time Frame
Plain radiographs		1 Year
VAS Pain	Visual analogue acale 1-10	1 Year
VAS Satisfaction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute acromioclavicular joint dislocation
18 years or older

Exclusion Criteria:

Unable to sign informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wender Figved, MD, PhD	Baerum Hospital, Vestre Viken, Norway	Study Director
Odd A Lien, MD	Baerum Hospital, Vestre Viken, Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asker and Baerum Hospital		Baerum	Rud	0407	Norway

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D004204	Joint Dislocations

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

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Browse Branches

Not provided