NCT05504538

Brief Summary

studying coracoid tunnel widening after arthroscopic fixation of acute acromioclavicular joint (ACJ) dislocation using TightRope system and its correlation with loss of reduction and the functional scores.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

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

July 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2018

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

August 2, 2022

Last Update Submit

August 17, 2022

Conditions

Orthopedic DisorderOrthopedic Devices Associated With Misadventures

Keywords

Acute acromioclavicular joint injury .TightRope .Coracoid tunnel dilatation.Loss of reduction.

Outcome Measures

Primary Outcomes (2)

  • Coracoid tunnel diameter difference between immediate postoperative and final follow up

    Radiological outcome using CT scans

    1 year

  • Coraco-clavicular distance immediate postoperative and at final follow up

    Radiological outcome using X-rays

    1 year

Secondary Outcomes (3)

  • Constant-Murley shoulder score. Ranges from 0 representing worst outcome to 100 representing best outcome

    1 year

  • Disability of arm shoulder and Hand score ( DASH score) highest is 100 which represents worst outcome while lowest is 0 representing best possible outcome

    1 year

  • Oxford Shoulder score, a questionnaire of 12 questions each scores from 1 to 5. 1 being the fewest symptoms, 5 being the worst. The total score is 60 marks, the higher the score the worse the outcomes

    1 year

Study Arms (1)

patient with Acute acromioclavicular joint injury

EXPERIMENTAL

patient with Acute acromioclavicular joint injury

Procedure: arthroscopic fixation of Acute acromioclavicular joint injury using tight ropeDevice: Tight rope

Interventions

arthroscopic fixation of Acute acromioclavicular joint injury using tight ropePROCEDURE

arthroscopic fixation of Acute acromioclavicular joint injury using tight rope

patient with Acute acromioclavicular joint injury
Tight ropeDEVICE

Adjustable button device from Arthrex Naples USA

patient with Acute acromioclavicular joint injury

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with acute (≤ 3 weeks after injury) Rockwood grade III-V ACJ dislocation

You may not qualify if:

  • Patients with associated coracoid fracture, associated rotator cuff tears or glenohumeral arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal Diseases

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
Principal investigator, Consultant of Trauma and Orthopedics

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 17, 2022

Study Start

July 1, 2016

Primary Completion

July 15, 2018

Study Completion

July 15, 2018

Last Updated

August 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share