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Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques

NCT ID: NCT03887234

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-10-19

Brief Summary

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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.

Detailed Description

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A modified arthroscopic technique for coracoclavicular ligament reconstruction was used based on a previous technique where the supportive device and the semi tendon graft share the clavicular and coracoid drill holes. A notable problem with the previous technique was large protruding suture knots on the washer and clavicle, which could predispose to wound infection. In this new modified technique, new implants were introduced. The new implant hides the suture knot and less foreign material is needed.

The purpose of this study is to follow the patients operated using the new implants with special attention to early clavicular wound healing. A further aim is to compare a technique where the semitendinosus graft runs through clavicular and coracoid drill holes versus a technique where the graft runs under the coracoid process.

Conditions

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AC Joint Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized follow-up study. Two groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Either the two operation methods is chosen by opening a sealed envelope.

Study Groups

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Through the coracoid

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

Group Type ACTIVE_COMPARATOR

Coracoclavicular ligament reconstruction

Intervention Type PROCEDURE

Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation

Around the coracoid

The semitendinosus tendon graft goes around the coracoid.

Group Type EXPERIMENTAL

Coracoclavicular ligament reconstruction

Intervention Type PROCEDURE

Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation

Interventions

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Coracoclavicular ligament reconstruction

Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Clinical diagnosis of chronic acromioclavicular luxation

Exclusion Criteria

Severe new trauma after the treatment
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Dr Juha Ranne

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juha O Ranne, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Turku, Finland

Locations

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Paavo Nurmi Centre, University of Turku

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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R18114

Identifier Type: -

Identifier Source: org_study_id