Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques

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

Study Overview

• Status: Completed
• Conditions: AC Joint Dislocation
• Intervention / Treatment: Procedure: Coracoclavicular ligament reconstruction

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20520
    • Paavo Nurmi Centre, University of Turku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Clinical diagnosis of chronic acromioclavicular luxation

Exclusion Criteria:

Severe new trauma after the treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Through the coracoid; The semitendinosus tendon graft goes through the 4.5 mm coracoid drill hole.	Procedure: Coracoclavicular ligament reconstruction; Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation
Experimental: Around the coracoid; The semitendinosus tendon graft goes around the coracoid.	Procedure: Coracoclavicular ligament reconstruction; Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Clavicular tunnel diameter	Describes possible adverse expansion of the tunnel; millimeters	The measure is taken postoperatively and after two years follow-up
Coracoclavicular distance	Describes possible adverse increase of the coracoclavicular distance; millimeters	The measure is taken postoperatively and after two years follow-up

Collaborators and Investigators

• Sponsor: University of Turku
• Investigators: Principal Investigator: Juha O Ranne, M.D., Ph.D., University of Turku, Finland

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): October 19, 2020
• Study Completion (Actual): October 19, 2022

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Estimate): December 26, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: R18114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No