Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques

AC Joint Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887234
• Other study ID #: R18114
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 19, 2022

Study information

• Verified date: December 2022
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 19, 2022
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

Clinical diagnosis of chronic acromioclavicular luxation

Exclusion Criteria:

Severe new trauma after the treatment

Related Conditions & MeSH terms

• AC Joint Dislocation

Intervention

Procedure:
• Coracoclavicular ligament reconstruction
Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation

Locations

Country	Name	City	State
Finland	Paavo Nurmi Centre, University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

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