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Completed

NCT Number: NCT03887234

Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques

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.

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Key information

Conditions

AC Joint Dislocation

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paavo Nurmi Centre, University of Turku

Turku, 20520, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of chronic acromioclavicular luxation

Exclusion criteria

Severe new trauma after the treatment

Treatment and study plan

Coracoclavicular ligament reconstruction

Procedure

Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation

Primary outcomes

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

    Time frame: two months

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

Secondary outcomes

  1. Constant score, scale 0-100, 100 denoting excellent

    Time frame: Score is taken postoperatively and after two years follow-up

    General shoulder test; describes the general state of the shoulder

  2. Simple shoulder test, scale 0-12, 12 denoting excellent

    Time frame: Score is taken postoperatively and after two years follow-up

    General shoulder test; describes the general state of the shoulder

  3. Nottingham clavicle score, scale 20-100, 100 denoting excellent

    Time frame: Score is taken postoperatively and after two years follow-up

    AC joint specific test; describes the state of the AC joint and clavicle

  4. Clavicular tunnel diameter

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

    Describes possible adverse expansion of the tunnel; millimeters

  5. Coracoclavicular distance

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

    Describes possible adverse increase of the coracoclavicular distance; millimeters

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Official study title

Arthroscopic Coracoclavicular Ligament Reconstruction Using Knot Hiding Titanium Implants: a Prospective Randomized Two-year Follow up Study Comparing Two Techniques

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Mar 22, 2019
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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