Arthroscopic Coracoclavicular Ligament Reconstruction Comparing Two Techniques

Study Overview
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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.

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

Conditions
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AC Joint Dislocation

Intervention / Treatment
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* Procedure: Coracoclavicular ligament reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of chronic acromioclavicular luxation Exclusion Criteria: Severe new trauma after the treatment

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized follow-up study. Two groups.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |