NCT05143853

Brief Summary

Comparing different treatement strategies in augmenting clavicle stabilisation

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 23, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

3 years

First QC Date

April 29, 2021

Last Update Submit

December 1, 2023

Conditions

Acromioclavicular Separation

Outcome Measures

Primary Outcomes (1)

  • Constant-Murley score, minimum score 1, maximum score 100 (higher = better)

    patient-reported outcome measure (PROM)

    1 year

Secondary Outcomes (3)

  • SACS - specific AC score, minimum score 1, maximum score 100 (higher = better)

    1 year

  • Horizontal RTG measurements, measured in mm

    1 year

  • Horizontal RTG measurements, measured in mm2

    1 year

Study Arms (2)

group with tape augmentation of acromioclavicular (AC) joint

ACTIVE COMPARATOR

patients randomised in this group will have additional tape fixation around AC joint. Both groups will however have fixation in CC area.

Procedure: non-absorbable tape fixation around AC jointProcedure: coracoclavicular (CC) fixation

group without tape augmentation of AC joint

SHAM COMPARATOR

patients randomised in this group will not have additional tape fixation around AC joint. Both groups will however have fixation in CC area.

Procedure: no fixation around AC jointProcedure: coracoclavicular (CC) fixation

Interventions

non-absorbable tape fixation around AC jointPROCEDURE

fixation around AC joint with tape in different configurations

group with tape augmentation of acromioclavicular (AC) joint
no fixation around AC jointPROCEDURE

there will be no additional fixation around AC joint in this group

group without tape augmentation of AC joint
coracoclavicular (CC) fixationPROCEDURE

mandatory coracoclavicular fixation with to suspensory systems, comprised of non-absorbable tapes and metal buttons

group with tape augmentation of acromioclavicular (AC) jointgroup without tape augmentation of AC joint

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • consensus indication for surgical treatment of AC syndesmolysis
  • OP in 3 weeks after injury
  • patient age between 16 and 65 years
  • normal shoulder function before injury

You may not qualify if:

  • open injury
  • ipsilateral arm/shoulder girdle/hand injuries
  • very low patient's physical demands
  • previous injuries of the affected area
  • Rockwood classification 1, 2, or 6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2021

First Posted

December 3, 2021

Study Start

April 23, 2021

Primary Completion

May 1, 2024

Study Completion

September 1, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

SL(1)