NCT03887234

Brief Summary

This study follows early wound healing using knot hiding titanium implants in coracoclavicular ligament reconstruction. A further aim is to compare two techniques where the semitendinosus tendon graft either runs through the coracoid drill hole or goes around the coracoid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2022

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

2.1 years

First QC Date

January 21, 2019

Last Update Submit

December 23, 2022

Conditions

AC Joint Dislocation

Outcome Measures

Primary Outcomes (1)

  • Total number of wound infections in the clavicular describing the safety of the used implant

    Clinical sign questionnaire, scale 0-1 (no-yes)

    two months

Secondary Outcomes (5)

  • Constant score, scale 0-100, 100 denoting excellent

    Score is taken postoperatively and after two years follow-up

  • Simple shoulder test, scale 0-12, 12 denoting excellent

    Score is taken postoperatively and after two years follow-up

  • Nottingham clavicle score, scale 20-100, 100 denoting excellent

    Score is taken postoperatively and after two years follow-up

  • Clavicular tunnel diameter

    The measure is taken postoperatively and after two years follow-up

  • Coracoclavicular distance

    The measure is taken postoperatively and after two years follow-up

Study Arms (2)

Through the coracoid

ACTIVE COMPARATOR

The semitendinosus tendon graft goes through the 4.5 mm coracoid drill hole.

Procedure: Coracoclavicular ligament reconstruction

Around the coracoid

EXPERIMENTAL

The semitendinosus tendon graft goes around the coracoid.

Procedure: Coracoclavicular ligament reconstruction

Interventions

Coracoclavicular ligament reconstructionPROCEDURE

Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation

Around the coracoidThrough the coracoid

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic acromioclavicular luxation

You may not qualify if:

  • Severe new trauma after the treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paavo Nurmi Centre, University of Turku

Turku, 20520, Finland

Location

Study Officials

  • Juha O Ranne, M.D., Ph.D.

    University of Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Either the two operation methods is chosen by opening a sealed envelope.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized follow-up study. Two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 21, 2019

First Posted

March 22, 2019

Study Start

September 1, 2018

Primary Completion

October 19, 2020

Study Completion

October 19, 2022

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations

FI(1)