NCT01274884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

3.3 years

First QC Date

January 11, 2011

Last Update Submit

November 17, 2014

Conditions

Acromioclavicular Joint Dislocation

Keywords

AcromioclavicularInjuryDislocationSurgery

Outcome Measures

Primary Outcomes (1)

  • Constant score

    Shoulder outcome score

    1 Year

Secondary Outcomes (3)

  • Plain radiographs

    1 Year

  • VAS Pain

    1 Year

  • VAS Satisfaction

    1 Year

Study Arms (1)

Acromioclavicular joint dislocation

ACTIVE COMPARATOR

Surgery: Arthroscopic repair using the Tightrope fixation device

Procedure: Tightrope fixation

Interventions

Tightrope fixationPROCEDURE

Arthroscopic repair

Also known as: Tightrope (R) (Arthrex, Naples, Florida)
Acromioclavicular joint dislocation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute acromioclavicular joint dislocation
  • years or older

You may not qualify if:

  • Unable to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asker and Baerum Hospital

Baerum, Rud, 0407, Norway

Location

MeSH Terms

Conditions

Wounds and InjuriesJoint Dislocations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Wender Figved, MD, PhD

    Baerum Hospital, Vestre Viken, Norway

    STUDY DIRECTOR

  • Odd A Lien, MD

    Baerum Hospital, Vestre Viken, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Orthopaedic Surgeon

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 12, 2011

Study Start

March 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

NO(1)