Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

Study Overview
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Brief Summary
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To evaluate patient function, radiographic changes and complication rates of acute coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an augmentation to repair.

Detailed Description
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Acromioclavicular (AC) joint dislocations comprise up to 12% of shoulder girdle injuries. Many methods of reconstructing the coracoclavicular ligaments, which provide vertical stability of the acromioclavicular joint, have been described. The use of tendon graft to augment the reconstruction provides improved biomechanical stability, less radiographic changes postoperatively including loss of reduction, and improved function. However, the use of a tendon graft necessitates larger drill holes in the clavicle when compared to suture-only repair constructs. The size and placement of these tunnels in the clavicle have been associated with a higher rate of complications. It has been shown that repairs in the setting of acute injury demonstrate less complications including loss of reduction when compared with chronic dislocations. However, other reports describing repair of acute AC joint dislocations without graft augmentation have described significant changes in coracoclavicular distance with routine follow up radiographs, and up to 90% implant migration rates. While use of tendon graft would be expected to provide further stability, they may in turn cause an increased complication rate. To determine complication rates in the reconstruction of AC joint dislocations with and without the use of tendon graft. Determine patient satisfaction, the ASES, Constant, SF-12, SANE, SST scores of shoulders that undergo reconstruction of acute AC joint dislocations with and without the use of graft. The investigation aims to determine whether or not graft should be used in the reconstruction of acute AC joint dislocations.

Official Title
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A Randomized, Prospective Trial Comparing Reconstruction Of Acute Coracoclavicular Ligament Disruption With and Without Tendon Graft

Conditions
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Acromioclavicular Joint Dislocation

Intervention / Treatment
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* Procedure: tendon graft
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Displaced acromioclavicular joint dislocation sustained within 3 weeks of surgery recommended for operative fixation age 18 years or older Exclusion Criteria: Open dislocation previous acromioclavicular surgery unable to follow study protocol concomitant injury requiring surgery (rotator cuff repair, biceps tenotomy/tenodesis) active infection unable to follow postoperative rehabilitation guidelines reconstruction with coracoclavicular screw or hook plate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC repair with tendon graft<br>acromioclavicular repair with tendon graft. | Procedure: tendon graft<br>* JRF Orthopedics Tendon Graft<br>|
| Active Comparator: AC repair with no tendon graft<br>acromioclavicular repair without tendon graft/no intervention | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rates with and without the use of graft tendons | loss of radiographic reduction, infection, need for more surgery | 2 years | 
| (American Shoulder Elbow Society (ASES) | Shoulder Function survey (17 multiple choice questions). | 2 years | 
| Instability Index Constant Score (ISIS) | Shoulder Instability survey for last 4 weeks (yes/no and multiple choice). Score is graded poor, fair, good, excellent. | 2 years | 
| Simple Shoulder Test (SST) | Shoulder Function survey (12 yes/no questions) | 2 years | 
| Short Form-12 | This survey assesses patient's health satisfaction. This information will help keep track of how patients feel and how well patients are able to do your usual activities. (12 multiple choice questions) | 2 years | 
| Single Assessment Numerical Evaluation (SANE) | Patient assessment rating from 0-100 shoulder normality | 2 years | 
| Visual Analog Score (VAS) | Measurement of shoulder pain from 0 (no pain) to 10 (unbearable distress) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder, orthopaedics