Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques

Not Applicable

Completed

• Conditions: AC Joint Dislocation
• Interventions: Procedure: Coracoclavicular ligament reconstruction

• Registration Number: NCT03887234
• Lead Sponsor: University of Turku

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Primary Completion: 2020-10-19
• Study Completion: 2022-10-19
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Clinical diagnosis of chronic acromioclavicular luxation

Exclusion Criteria

Severe new trauma after the treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Around the coracoid	Coracoclavicular ligament reconstruction	The semitendinosus tendon graft goes around the coracoid.
Through the coracoid	Coracoclavicular ligament reconstruction	The semitendinosus tendon graft goes through the 4.5 mm coracoid drill hole.

Primary Outcome Measures

Name	Time	Method
Total number of wound infections in the clavicular describing the safety of the used implant	two months	Clinical sign questionnaire, scale 0-1 (no-yes)

Secondary Outcome Measures

Name	Time	Method
Clavicular tunnel diameter	The measure is taken postoperatively and after two years follow-up	Describes possible adverse expansion of the tunnel; millimeters
Coracoclavicular distance	The measure is taken postoperatively and after two years follow-up	Describes possible adverse increase of the coracoclavicular distance; millimeters
Simple shoulder test, scale 0-12, 12 denoting excellent	Score is taken postoperatively and after two years follow-up	General shoulder test; describes the general state of the shoulder
Nottingham clavicle score, scale 20-100, 100 denoting excellent	Score is taken postoperatively and after two years follow-up	AC joint specific test; describes the state of the AC joint and clavicle
Constant score, scale 0-100, 100 denoting excellent	Score is taken postoperatively and after two years follow-up	General shoulder test; describes the general state of the shoulder

Trial Locations

Locations (1)

Paavo Nurmi Centre, University of Turku; 🇫🇮 Turku, Finland